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Clinical trials for bioequivalence OR “comparative bioavailability”

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   43862   clinical trials with a EudraCT protocol, of which   7285   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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    29 result(s) found for: bioequivalence OR “comparative bioavailability”. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-004767-21 Sponsor Protocol Number: MK-0518B-258 Start Date*: 2015-05-04
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: MK-0518B (EU Sourced Lamivudine) Bioequivalence Study
    Medical condition: N/A
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001896-63 Sponsor Protocol Number: E3810-A001-015 Start Date*: 2016-06-27
    Sponsor Name:Eisai Medical Research Inc.
    Full Title: An Ascending Bioavailability of a New Oral Suspension of E3810
    Medical condition: Bioavailability/Bioequivalence
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-000436-62 Sponsor Protocol Number: GS-US-380-4547 Start Date*: 2021-02-12
    Sponsor Name:Gilead Sciences, Inc
    Full Title: A Phase 1, Single-Dose, Cross-Over Study Evaluating the Relative Bioavailability and Food Effect of a Pediatric Tablet for Oral Suspension of Bictegravir/Emtricitabine/Tenofovir Alafenamide and the...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004656-30 Sponsor Protocol Number: MK-1439-052 Start Date*: 2016-11-16
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Study of the Comparative Bioavailability of Two Second-Generation Investigational Pediatric Oral Granule Formulations of MK-1439 Compared to the Adult Formulation. Additional PIP decision nu...
    Medical condition: HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003005-41 Sponsor Protocol Number: CS0866-A-U101 Start Date*: 2015-07-24
    Sponsor Name:Sankyo Pharma Development
    Full Title: A Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of a Compounded 4 mg/mL Olmesartan Medoxomil Suspension (Total Dose 40 mg) and 40 mg Olmesartan Medoxomil Tablets (Beni...
    Medical condition: Not applicable - Healthy Volunteer study
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004350-34 Sponsor Protocol Number: MK-5348-040 Start Date*: 2014-10-29
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    Full Title: A Comparative Bioavailability Study of a Tablet versus an Investigational Oral Suspension of Vorapaxar
    Medical condition: Vorapaxar is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD).
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004866 10014501 Embolism - blood clot LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-005034-66 Sponsor Protocol Number: 20070293 Start Date*: 2014-11-13
    Sponsor Name:Amgen, Inc.
    Full Title: An Open-label, Randomized, Single-dose, 3-period, 3-treatment Crossover Study to Assess the Comparative Bioavailability of 5mg Cinacalcet Capsules to the 30mg Commercial Formulation Cinacalcet Tabl...
    Medical condition: Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma
    Disease: Version SOC Term Classification Code Term Level
    17.1 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004728-48 Sponsor Protocol Number: MK-1439-043 Start Date*: 2016-11-23
    Sponsor Name:Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc.
    Full Title: A Study to Evaluate the Comparative Bioavailability of the Investigational Oral Pediatric Minitablet Formulation of MK-1439 Compared to the Adult Formulation of MK-1439 in Healthy Adult Subjects
    Medical condition: HIV – Human Immunodeficiency Virus
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004392-41 Sponsor Protocol Number: MK-1439A-054 Start Date*: 2016-11-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Study of the Comparative Bioavailability of Two Investigational Pediatric Oral Granule Formulations of Lamivudine and Tenofovir Compared to the Adult Marketed Formulations. Other PIP decision ...
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001803-57 Sponsor Protocol Number: CLCZ696B2126 Start Date*: 2017-08-14
    Sponsor Name:Novartis Pharmaceuticals Corp
    Full Title: A randomized, study in healthy subjects to determine the bioavailability of 200 mg LCZ696 mini-tablet compared to the 200 mg LCZ696 final market image tablet
    Medical condition: Study in healthy subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003433-33 Sponsor Protocol Number: 8669-060 Start Date*: 2011-07-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Single Dose Biocomparison Study to Assess two Pediatric Formulations of MK-8669 to the Provisional Market Formulation in Healthy Subjects
    Medical condition: Sarcoma
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041299 Soft tissue sarcomas HLGT
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006008 Bone sarcoma NOS LLT
    Population Age: Adults Gender: Male
    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: 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: 2012-000299-40 Sponsor Protocol Number: CRAD001C2121 Start Date*: 2016-05-12
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, open label, two-way crossover study investigating the relative bioavailability of a single 5 mg dose of everolimus administered as either 5x1 mg everolimus intact tablets or 5x1 mg ev...
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2020-002885-15 Sponsor Protocol Number: AI424-567 Start Date*: 2020-07-15
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed‑dose Combination Formula...
    Medical condition: HIV in paediatric population
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10020172 HIV infection NOS LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001245-89 Sponsor Protocol Number: BDR4580 Start Date*: 2015-04-13
    Sponsor Name:Sanofi-aventis
    Full Title: Relative bioavailability study between 75 mg tablet and 75 mg solution of Clopidogrel (SR25990C) after single oral administration to young healthy men. Open, crossover, randomized and monocenter study
    Medical condition: Young healthy men (intended indication cardiovascular disease)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004865 10071110 Atherothrombosis prophylaxis LLT
    Population Age: Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-000689-40 Sponsor Protocol Number: VX19-661-012 Start Date*: 2020-02-25
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability of a Granule Formulation of Tezacaftor and Ivacaftor Compared to a Fixed-dose Combination Tablet in Healt...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004901-25 Sponsor Protocol Number: MEK115892 Start Date*: 2012-07-25
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: An Open-Label, Two-Period, Randomized, Crossover Study to Assess the Relative Bioavailability of GSK1120212 Tablet Formulation and the GSK1120212 Pediatric Oral Solution Formulation Following Si...
    Medical condition: GSK1120212 is currently being developed for a number of solid tumors, including metastatic BRAF-mutant melanoma (Phase 3), pancreatic cancer (Phase 2) and non small cell lung cancer (Phase 2), and ...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021156-26 Sponsor Protocol Number: VX10-950-022 Start Date*: 2012-02-17
    Sponsor Name:Vertex Pharmaceuticals Inc.
    Full Title: A Phase 1, Randomized, Open-label, Single-Dose, Crossover, Relative Bioavailability, and Food-Effect Study of a Pediatric Chewable Tablet Formulation Relative to a 375-mg Core Tablet Formulation of...
    Medical condition: chronic hepatitis c virus genotype 1 infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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