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Clinical trials for Drug Formulation

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    438 result(s) found for: Drug Formulation. Displaying page 1 of 22.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2015-004441-17 Sponsor Protocol Number: CFAM810B2303 Start Date*: 2016-04-12
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediat...
    Medical condition: Herpes Simplex
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-002254-23 Sponsor Protocol Number: VX15-809-014 Start Date*: 2019-06-10
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 1, Randomized, Open-label Study to Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Lumacaftor in Combination With Ivacaftor in Healt...
    Medical condition: Healthy Adult Subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2023-000381-34 Sponsor Protocol Number: CL019_168 Start Date*: 2023-05-30
    Sponsor Name:ChemoCentryx
    Full Title: An Open Label, Randomized, Crossover, Single Dose Bioavailability Study in Healthy Adult Subjects to Evaluate the Pharmacokinetic Profile of an Exploratory Avacopan Pediatric Liquid Formulation Com...
    Medical condition: Anti-Neutrophil Cytoplasmic Antibody associated vasculitis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000278-13 Sponsor Protocol Number: P16-07/BP052 Start Date*: Information not available in EudraCT
    Sponsor Name:BIOPROJET PHARMA
    Full Title: Palatability testing in children of a new paediatric formulation of Racecadotril as oral suspension strawberry-flavored administered via an oral graduated syringe compared to the current formulatio...
    Medical condition: Young healthy volunteers (7-12 years)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004856 10055955 Acute diarrhoea LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-004044-37 Sponsor Protocol Number: GS-US-342-1142 Start Date*: 2017-12-07
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 1 Relative Bioavailability and Food Effect Study of a Pediatric Oral Granule Formulation of SOF/VEL in Healthy Adult Subjects.
    Medical condition: Chronic Hepatitis C virus infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-001967-70 Sponsor Protocol Number: AC-052-367 Start Date*: 2005-10-13
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertensi...
    Medical condition: Idiopathic or familial pulmonary arterial hypertension
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-006481-21 Sponsor Protocol Number: 79916 Start Date*: 2022-09-08
    Sponsor Name:Erasmus MC - Sophia Kinderziekenhuis
    Full Title: Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation
    Medical condition: Renal transplant recipients
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003727-10 Sponsor Protocol Number: MO40598 Start Date*: 2019-12-16
    Sponsor Name: Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche Ltd
    Full Title: A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE SAFETY AND EFFICACY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB PLUS GEMCITABINE PLUS OXALIPLATIN (R-GEMOX) VERSUS R-G...
    Medical condition: Relapsed/refractory diffuse large B-cell lymphoma (DLBL)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10012857 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory LLT
    21.1 100000004864 10012856 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent LLT
    21.0 100000004864 10012855 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Ongoing) GB (GB - no longer in EU/EEA) IE (Completed) FI (Completed) SE (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-000683-84 Sponsor Protocol Number: 05-FOR-02 Start Date*: 2006-05-10
    Sponsor Name:Andi-Ventis Ltd.
    Full Title: A DOUBLE BLIND, DOUBLE DUMMY, GROUP COMPARATIVE STUDY TO ASSESS THERAPEUTIC EQUIVALENCE OF A NEW GENERIC FORMOTEROL 12 uG DRY POWDER FORMULATION WITH OXIS 12uG TURBUHALER IN ADOLESCENT AND ADULT AS...
    Medical condition: asthma bronchiale
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2014-002588-14 Sponsor Protocol Number: APOTEL-02 Start Date*: 2014-09-22
    Sponsor Name:UNI-PHARMA SA
    Full Title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE IV CLINICAL STUDY OF THE EFFICACY AND SAFETY OF A NEW FORMULATION OF PARACETAMOL FOR THE MANAGEMENT OF FEVER OF INFECTIOUS ORIGIN
    Medical condition: Fever due to infection of the upper respiratory tract, of the lower respiratory tract, acute pyelonephritis or of the skin and soft tissues.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10042613 - Surgical and medical procedures 10049541 Antipyresis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2013-002861-20 Sponsor Protocol Number: 2012-01 Start Date*: 2014-01-07
    Sponsor Name:Lek Pharmaceuticals d.d.
    Full Title: A multi-centre, randomised, double-blind, parallel-group phase III study to investigate the efficacy, safety, and tolerability of a generic calcipotriol-betamethasone ointment formulation compared ...
    Medical condition: Chronic stable plaque psoriasis.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-003736-22 Sponsor Protocol Number: M17-142 Start Date*: 2020-07-08
    Sponsor Name:AbbVie Inc.
    Full Title: Bioavailability and Food Effect of Experimental Glecaprevir + Pibrentasvir Pediatric Formulation in Healthy Adult Subjects
    Medical condition: Hepatitis C virus (HCV) infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001361-28 Sponsor Protocol Number: GO29365 Start Date*: 2015-10-07
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A Phase Ib/II study evaluating the safety, tolerability and anti-tumor activity of polatuzumab vedotin in combination with rituximab (R) or obinutuzumab (G) plus bendamustine (B) in relapsed or ref...
    Medical condition: Follicular Lymphoma and Diffuse Large B-Cell Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10012857 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory LLT
    20.0 100000004864 10012855 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) LLT
    20.1 100000004864 10012856 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) NL (Completed) FR (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-023770-39 Sponsor Protocol Number: EFC11629 Start Date*: 2011-10-28
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin glargine and Lantus® both in combination with oral antihyperglyc...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    16.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PT (Completed) ES (Completed) HU (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2021-004002-21 Sponsor Protocol Number: Bio-Eq-20 Start Date*: 2021-11-26
    Sponsor Name:AOP Orphan Pharmaceuticals GmbH
    Full Title: A single center, open-label, two-period, non-randomized, paired-design study to compare steady-state plasma levels following switch from a 10 mg/ml treprostinil formulation to a 20 mg/ml treprostin...
    Medical condition: pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000605-84 Sponsor Protocol Number: XPORT-DLBCL-030 Start Date*: 2020-09-16
    Sponsor Name:Karyopharm Therapeutics Inc.
    Full Title: A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DL...
    Medical condition: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10012856 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent LLT
    21.1 100000004864 10012857 Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing) FR (Ongoing) IT (Ongoing) GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-001333-14 Sponsor Protocol Number: CCOA566B2303 Start Date*: 2012-03-09
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, investigator-blinded, multicenter, parallel group study to compare efficacy, safety and tolerability of Coartem® dispersible tablet formulation vs. Coartem® 6-dose crushed tablet in t...
    Medical condition: This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused by Plasmodium falciparum in children.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001568-12 Sponsor Protocol Number: 16-02/CalciBet-S Start Date*: 2016-10-18
    Sponsor Name:Dermapharm AG
    Full Title: A multi-centre, randomised, double-blind, parallel-group phase III study to investigate the efficacy, safety, and tolerability of a generic calcipotriol-betamethasone ointment formulation compared ...
    Medical condition: chronic stable plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10040785 - Skin and subcutaneous tissue disorders 10071117 Plaque psoriasis LLT
    19.1 10040785 - Skin and subcutaneous tissue disorders 10050576 Psoriasis vulgaris LLT
    19.1 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-005248-41 Sponsor Protocol Number: DDD17Fenogal Start Date*: 2017-05-17
    Sponsor Name:KU Leuven - Drug Delivery and Disposition
    Full Title: Influence of gastrointestinal lipid digestion in the absorption of fenofibrate from a lipid-based formulation
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001326-25 Sponsor Protocol Number: MK-8228-030 Start Date*: 2019-05-27
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    Full Title: A Phase 2b open-label, single-arm study to evaluate pharmacokinetics, efficacy, safety and tolerability of letermovir in pediatric participants from birth to less than 18 years of age at risk of de...
    Medical condition: Cytomegalovirus (CMV) infection in pediatric allogeneic HSCT recipients
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10011831 Cytomegalovirus infection PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) Outside EU/EEA FR (Completed) PL (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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