Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Bioequivalence

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   44336   clinical trials with a EudraCT protocol, of which   7366   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    69 result(s) found for: Bioequivalence. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2013-005062-19 Sponsor Protocol Number: FDA-BE1 Start Date*: 2015-01-07
    Sponsor Name:Medical University of Graz - Division of Endocrinology and Metabolism
    Full Title: An exploratory study to evaluate dermal open flow microperfusion’s (dOFM) ability to assess bioequivalence and non-bioequivalence of topical acyclovir formulations in healthy volunteers
    Medical condition: healthy volunteers (the medication that is used is authorized)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2004-001114-14 Sponsor Protocol Number: ST261-DS-02-002 Start Date*: 2004-10-22
    Sponsor Name:SIGMA-TAU
    Full Title: BIOAVAILABILITY AND BIOEQUIVALENCE OF TWO ORAL FORMULATION OF L-PROPIONYLCARNITINE TABLET VS SACHET IN HEALTHY VOLUNTEERS AT THE DOSE OF 2 G OPEN, RANDOMISED, TWO-WAYS CROSS-OVER, SINGLE DOSE STUDY
    Medical condition: BIOEQUIVALENCE /BIOAVAILABILITY STUDY
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001245-40 Sponsor Protocol Number: FARM9X59Y4 Start Date*: 2013-06-05
    Sponsor Name:
    Full Title: CLINICAL AND PHARMACOKINETICS STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®)
    Medical condition: PARKINSON'S DISEASE
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004852 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001442-34 Sponsor Protocol Number: IBUPAI0002 Start Date*: 2013-08-06
    Sponsor Name:McNeil AB
    Full Title: A SINGLE-DOSE, RANDOMIZED, TWO-PERIOD, CROSSOVER STUDY TO ASSESS BIOEQUIVALENCE BETWEEN TWO IBUPROFEN 200 MG TABLET FORMULATIONS, IN HEALTHY ADULTS.
    Medical condition: Pain
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004323-23 Sponsor Protocol Number: CVAL489K2101 Start Date*: 2017-08-21
    Sponsor Name:Novartis
    Full Title: An open-label, randomized, single dose, two period, crossover study to determine the bioequivalence between valsartan 160 mg pediatric final market image (FMI) formulation (solution) and clinical s...
    Medical condition: Hypertension
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002290-21 Sponsor Protocol Number: GMX07 Start Date*: 2014-04-30
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary...
    Medical condition: Primary immunodeficiency diseases
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2009-012082-54 Sponsor Protocol Number: VIAject-030J Start Date*: 2009-07-10
    Sponsor Name:BIODEL inc.
    Full Title: A Single Center, Double Blind, Randomized Crossover Study Evaluating the Bioequivalence of VIAject®7 compared to VIAject™25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAj...
    Medical condition: Type 1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045238 Type I diabetes mellitus without mention of complication LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000648-16 Sponsor Protocol Number: BAY59-7939/19365 Start Date*: 2017-06-21
    Sponsor Name:Bayer AG
    Full Title: Single-dose, open-label, randomized, 2-way crossover bioequivalence study of 10 mg granules for oral suspension rivaroxaban versus 10 mg tablets rivaroxaban under fasted condition in healthy subjects
    Medical condition: Prevention and treatment of thromboembolic disorders
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004866 10043640 Thrombosis venous LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000609-18 Sponsor Protocol Number: BAY59-7939/19366 Start Date*: 2017-06-20
    Sponsor Name:Bayer AG
    Full Title: Single-dose, open-label, randomized, 2-way crossover bioequivalence study of 20 mg granules for oral suspension rivaroxaban versus 20 mg tablets rivaroxaban under fed condition in healthy subjects
    Medical condition: Prevention and treatment of thromboembolic disorders
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004866 10043640 Thrombosis venous LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-001670-32 Sponsor Protocol Number: VIAject™ -012J Start Date*: 2008-08-07
    Sponsor Name:Biodel Inc.
    Full Title: A Single-Center, Double Blind Study Evaluating the Bioequivalence of the Pharmacokinetic and Pharmacodynamic Properties of Different Formulations of VIAject™ in Subjects with Type 1 Diabetes Mellitus
    Medical condition: Type 1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045238 Type I diabetes mellitus without mention of complication LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    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: 2020-002782-34 Sponsor Protocol Number: B1871061 Start Date*: 2020-09-03
    Sponsor Name:Pfizer Inc.
    Full Title: A phase 1, open-label, randomized, 2-period, 2 sequence, crossover study to evaluate the bioequivalence of Bosutinib pediatric capsule and the commercial tablet formulations in healthy participants...
    Medical condition: Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004864 10082178 Philadelphia positive chronic myeloid leukemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-005021-79 Sponsor Protocol Number: 72541 Start Date*: 2020-03-10
    Sponsor Name:Amsterdam UMC - location Academic Medical Centre (AMC)
    Full Title: Revised dosing recommendations of ciprofloxacin for patients with impaired renal function: a bioequivalence study.
    Medical condition: Ciprofloxacin exposure in patients treated for a bacterial infection.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    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: 2014-003595-23 Sponsor Protocol Number: CIP-DEX/001/14 Start Date*: 2014-12-17
    Sponsor Name:Watson Laboratories Inc.
    Full Title: A double-blinded, parallel-group, randomized, single dose study to assess the pharmacokinetic bioequivalence of ciprofloxacin (0.3%) and dexamethasone (0.1%) otic suspension (Indoco for Actavis) ve...
    Medical condition: Patients with current or previous history of acute otitis media (AOM) and recurrent acute otitis media (RAOM).
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10033079 Otitis media acute PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-000227-25 Sponsor Protocol Number: CRIT124DDE03 Start Date*: 2008-10-15
    Sponsor Name:Dept. Child & Adolescent Psychiatrie
    Full Title: A single-center, single-blind, randomized, oral dose cross-over study in prepuberal boys with ADHD to investigate efficacy and bioequivalence of 20 mg Ritalin LA® compared to 20 mg Medikinet® retar...
    Medical condition: Patients having a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) of any type according to DSM-IV criteria, as established by history, psychiatric examination and a structured diagnost...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-017481-23 Sponsor Protocol Number: SPD09P1401 Start Date*: 2010-10-15
    Sponsor Name:SmartPractice
    Full Title: Clinical Evaluation of T.R.U.E. TEST® Neomycin Sulfate and Potassium Dichromate Allergens: Bioequivalence of Vehicle Formulations
    Medical condition: Diagnosis of Allergic Contact Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056265 Allergic contact dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-004702-17 Sponsor Protocol Number: COMB157G2102 Start Date*: 2018-09-01
    Sponsor Name:Novartis Pharma AG
    Full Title: A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients
    Medical condition: Multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) EE (Completed) LV (Completed) LT (Completed) ES (Completed) PL (Completed) BG (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-000720-16 Sponsor Protocol Number: 3082B2-310-WW Start Date*: 2005-06-22
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals, Inc.
    Full Title: A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII...
    Medical condition: For all patients participating in the trial:Male subjects with severe or moderately severe hemophilia A (FVIII:C ≤ 2%) previously treated with ≥ 150 exposure days to any Factor VIII product.For pat...
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: HU (Completed) ES (Completed) DE (Completed) SE (Completed) FI (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002470-40 Sponsor Protocol Number: PROSORA Start Date*: 2017-11-16
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: Observational study of the effects of probenecid on the pharmacokinetics and pharmacodynamics of sorafenib (PROSORA-study)
    Medical condition: patients with unresectable hepatocellular cancer, advanced clear-cell renal cell carcinoma, locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun May 18 10:12:35 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA