Phase I – Bioequivalence

302 trials 14 recruiting

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A Single Dose, Fasting state, Crossover Replicate Bioequivalence Study of Naproxen 500 mg/Esomeprazole 20 mg, modified-release tablets (Anti… Ended

2024-515662-14-00 healthy subjects 2024-10-31
Open-label, randomized, two-treatment, two-period, two-sequence, cross-over, single dose, bioequivalence study comparing ISOPRINOSINE® FORTE… Ended

2024-514146-37-00 not applicable (submitted trial is a bioequivalence stu 2024-10-24
An open label, randomized, single dose, two-sequence, two-treatment, four-period, fully replicate, cross-over pharmacokinetic study comparin… Ended

2024-516942-21-00 Not applicable (submitted trial is a bioavailability st 2024-10-21
An open label, randomized, two-period, two-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Val… Ended

2024-516184-87-00 not applicable (submitted trial is a bioavailability st 2024-10-18
Bioequivalence clinical trial of dapagliflozin 10 mg tablets, after a single oral dose administration to healthy volunteers under fasting co… Ended

2024-515238-34-00 Diabetes 2024-10-10
An open label, balanced, randomized, two-treatment, four period, two-sequence, multiple-dose (steady-state), fully-replicate crossover bioeq… Ended

2024-512770-10-00 Rheumatoid arthritis, ulcerative colitis, atopic dermat 2024-10-07
Bioequivalence of Ruxolitinib 20 mg Tablets in Healthy Participants Under Fasting Conditions. Ended

2024-515947-49-00 No medical condition. 2024-10-07
Bio-equivalence of Rosuvastatin 10 mg Ended

2023-509661-21-00 Healthy volunteers 2024-10-03
Bioequivalence of Linagliptin 5 mg Film-Coated Tablets in Healthy Participants Under Fasting Conditions Ended

2024-516400-42-00 No medical condition. 2024-10-02
Clinical trial to compare availability in the body of the active substance nicotine as well as patch adhesion of the newly developed patch L… Ended

2023-503548-14-00 bioequivalence and patch adhesion trial; therapeutical 2024-09-30
An open label, randomized, crossover, two-period, two-sequence, single dose study to assess the relative bioavailability of Rotigotine 4.5 m… Ended

2024-515840-21-00 Not applicable (submitted trial is a bioavailability st 2024-09-30
Comparative Bioavailability of Cabozantinib Film-Coated Tablets in Healthy Participants Under Fasting Conditions Ended

2024-511647-25-00 No medical condition. 2024-09-24
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadaci… Ended

2024-512771-12-00 Axial spondyloarthritis 2024-09-17
Bioequivalence clinical trial of two formulations of bilastine. Ended

2024-515077-96-00 Healthy volunteers 2024-09-13
Ibuprofen 200 mg bioequivalence study Ended

2024-516161-36-00 not applicable (submitted trial is BE) 2024-09-13
A Randomized, Single-dose, Crossover, Two-period, Pilot Comparative Bioavailability Study of Alendronate 70 mg effervescent vs. Fosamax 70 m… Ended

2024-513615-26-00 not applicable (submitted trial is a comparative bioava 2024-09-12
Bioequivalence of Lenvatinib 10 mg Capsules versus Lenvima® 10 mg Capsules in Healthy Participants Under Fasting Conditions. Ended

2024-512908-19-00 No medical condition. 2024-09-09
A single-dose, randomized, two-period, two-sequence, crossover comparative bioavailability study on formulations containing ramipril, amlodi… Ended

2024-514456-32-00 hypertension 2024-09-09
Evaluation of bioequivalence of two products containing 400 mg ibuprofen and 100 mg caffeine: Ibuprofen / Caffeine 400 mg / 100 mg coated gr… Ended

2023-509752-34-00 No therapeutic indication in the current trial with hea 2024-09-07
A randomized, open-label, single dose, 2-way crossover bioequivalence study comparing apixaban 5 mg hard capsules (PG412 [Celon Pharma]) vs … Ended

2024-511526-31-00 Prevention of stroke and systemic embolism in adult pat 2024-08-20
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadaci… Ended

2024-512773-27-00 Rheumatoid arthritis, ulcerative colitis, atopic dermat 2024-08-19
Randomised, bioequivalence clinical trial of atorvastatin 80 mg capsules vs atorvastatin 80 mg film-coated tablets, after a single oral dose… Ended

2024-512596-12-00 Hypercholesterolaemia 2024-08-16
Bioequivalence of Amoxicillin and Clavulanic Acid 250 mg/62.5 mg/5 mL Powder for Oral Suspension versus Augmentin® Forte 250 mg/62.5 mg/5 mL… Ended

2024-513753-75-00 No medical condition. 2024-08-12
A pivotal, randomized, open-label, two-treatment, two-sequence, four periods, crossover clinical trial to evaluate the bioequivalence of sin… Ended

2023-509484-24-00 Healthy 2024-08-10