Phase I – Bioequivalence

295 trials 18 recruiting

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The pivotal bioequivalence study comparing the test product to the reference product, which belongs to the group of medicines used in treatm… Ended

2025-521400-21-00 Not applicable (submitted trial is a BE study in health 2025-05-15
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Naltrex… Ended

2024-519776-20-00 Alcohol dependence 2025-05-12
Multiple-Dose Study on the Bioequivalence of One Tablet of Gliclazide MR 120 mg (S005190) and Two Tablets of Gliclazide MR 60 mg (Diaprel® M… Ended

2024-519640-32-00 No medical condicion. 2025-04-22
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutam… Ended

2024-518209-16-00 Prostate cancer 2025-04-14
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutam… Ended

2024-518211-20-00 Prostate cancer 2025-04-14
A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on Dapagliflozin 10 mg film-coated t… Ended

2024-520212-18-00 intended for treatment of for the treatment of (2): • 2025-04-03
A Clinical Study to Compare the Impact of Multiple-dose Oral Administration of Macitentan, 10 mg versus 75 mg on Endothelin-1 Clearance, End… Ended

2024-517652-35-00 Pulmonary Arterial Hypertension 2025-04-01
The pivotal bioequivalence study comparing the test product to the reference product, which belong to the group of medicines used in treatme… Ended

2024-518988-35-00 Not applicable (submitted trial is a bioequivalence in 2025-04-01
A study comparing the new drug PG413 produced by Celon Pharma SA with the drug Eliquis available on the market in healthy volunteers. Ended

2024-519660-40-00 Prevention of stroke and systemic embolism in adult pat 2025-03-31
Randomised, crossover bioequivalence clinical trial of escitalopram 20 mg capsules versus escitalopram 20 mg film-coated tablets, after a si… Ended

2025-521069-28-00 Antidepressants 2025-03-21
Bioequivalence of Ruxolitinib 25 mg Tablets in Healthy Participants Under Fasting Conditions Ended

2025-520716-34-00 No medical condition. 2025-03-17
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Brivara… Ended

2024-516500-42-00 Epilepsy 2025-03-13
Evaluation of the bioequivalence of two products containing esomeprazole under fed conditions: Esomeprazole-Syrup 40 mg dose (Test) vs. Nexi… Ended

2024-512674-97-00 No therapeutic indication in the current trial with hea 2025-03-11
Bioequivalence of Lisdexamfetamine dimesylate 70 mg Capsules in Healthy Participants Under Fasting Conditions. Ended

2024-516826-79-00 No medical condition. 2025-03-10
Bioequivalence of Lisdexamfetamine dimesylate 20 mg Capsules in Healthy Participants Under Fasting Conditions. Ended

2024-516827-14-00 No medical condition. 2025-03-10
A Phase I, Randomised, Open Label, Single Center, Single Oral Dose, Three Treatment, Three Period, Three Sequence, Change-over Bioequivalenc… Ended

2024-514198-23-00 Healthy volunteers, therapeutic indication not studied 2025-03-05
Bioequivalence clinical trial of two formulations of ezetimibe/atorvastatin Ended

2024-520303-62-00 Healthy volunteers 2025-03-04
A study to compare the absorption of two tablet strengths with the absorption of a solution. Ended

2024-519835-41-00 Parkinson's Disease 2025-02-28
A RANDOMIZED PHASE I, DOUBLE-BLIND, PARALLEL, COMPARATIVE ASSESSMENT OF PHARMACOKINETICS, SAFETY, PHARMACODYNAMICS, AND IMMUNOGENICITY OF LT… Ended

2023-505908-28-00 Chronic spontaneous urticaria 2025-02-26
A Single Dose, Fast state, Crossover Replicate Bioequivalence Study of NITROFURANTOIN 100 mg prolonged-release capsules (IASIS PHARMA) vs.FU… Ended

2024-517967-22-00 healthy subjects 2025-02-25
A pilot, open label, single dose, randomized, four-period, four-sequence, four-treatment crossover, comparative bioavailability study of UDC… Ended

2024-519920-26-00 UDCA causes a reduction in cholesterol saturation of th 2025-02-20
Randomised, crossover bioequivalence clinical trial of vortioxetine 20 mg film-coated tablets, after a single oral dose administration to he… Ended

2024-516497-29-00 Antidepressant 2025-02-11
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Bosutinib… Ended

2024-516489-12-00 myeloid leukemia 2025-01-31
Bioequivalence clinical trial of two formulations of vortioxetine. Ended

2024-519398-21-00 Healthy volunteers 2025-01-30