Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions
The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions.
- Trial name
- NCT00778245
- Testing
- cefprozil 500mg tablets
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteers
A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants
The study involves 4 injections of insulin lispro and its purpose is to: Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
- Trial name
- NCT02111083
- Testing
- Insulin Lispro
- Where
- Singapore
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents
The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI)…
- Trial name
- NCT04236453
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, Darunavir, Emtricitabine/Tenofovir Alafenamide
- Where
- Netherlands
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Healthy
A Study on the Correlation of Drug Metabolism and Human Body Composition Based on the Bioequivalence Trial of Progesterone Sustained-release Vaginal Gel
The aim of this observational study is to investigate the impact of body composition on the absorption, distribution, and metabolism of drugs.
- Trial name
- NCT07097246
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Healthy
Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of Depakote® ER Tablets following a single…
- Trial name
- NCT00974441
- Testing
- Divalproex Sodium, Depakote®
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsules Under Fasting Conditions
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr.
- Trial name
- NCT01045642
- Testing
- Omeprazole
- Where
- India
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets relative to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg)…
- Trial name
- NCT00649194
- Testing
- Rabeprazole Sodium Delayed-Release Tablets 20 mg, Aciphex® Tablets 20 mg
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2 x 25 mg) dose administration under fed…
- Trial name
- NCT00647751
- Testing
- Lamotrigine Tablets 25 mg, Lamictal® Tablets 25 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Under Fasting Conditions
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fasting conditions.
- Trial name
- NCT00870142
- Testing
- AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose, Norvasc® 10 mg Tablets
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence Study of Donepezil Hydrochloride 10 mg Tablets Under Fasting Conditions
This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover study was conducted to compare the relative bioavailability of equal doses of the test and reference products under fasted…
- Trial name
- NCT01276067
- Testing
- Donepezil
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Lansoprazole 30 mg DR Capsule Fasting Study
The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT01045967
- Testing
- Lansoprazole, Prevacid®
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions
An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
- Trial name
- NCT01052792
- Testing
- Naproxen Sodium
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Invasive Candidiasis
Evaluate Bioequivalence of Micafungin (50mg/Vial)
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of micafungin (50 mg/vial) after intravenous infusion of 50 mg micafungin in healthy volunteers under fasting conditions
- Trial name
- NCT05496725
- Testing
- Micafungin
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Healthy
Bioequivalence Study of Propofol Medium and Long Chain Fat Emulsion Injection in Healthy Chinese Subjects
This study assessed the bioequivalence and safety of a single dose of Propofol Medium/Long Chain Fat Emulsion Injection (Test product, Haisco Pharmaceutical Group Co., Ltd.) compared to the reference product (Propofol Medium/Long…
- Trial name
- NCT07057609
- Testing
- Tested Propofol Medium and Long Chain Fat Emulsion Injection (T), Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy
Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under…
- Trial name
- NCT00648934
- Testing
- Topiramate Sprinkle Capsules 25 mg, Topamax® Sprinkle Capsules 25 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence
Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions
This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the comparative bioavailability of fluconazole in the two formulations in healthy…
- Trial name
- NCT04038008
- Testing
- Fluconazole, Diflucan®
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions
To compare the rate of absorption and oral bioavailability of a test formulation of Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product…
- Trial name
- NCT00864448
- Testing
- Ramipril10 mg Capsules, single dose, Atlace® 10 mg capsules, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Attention Deficit/Hyperactivity Disorder (ADHD)
To Compare and Evaluate the Oral Bioavailability of Lisdexamfetamine 70 mg Capsule With That of Elvanse® 70 mg Capsules, Hard Lisdexamfetamine Dimesylate in Healthy, Adult, Human Subjects Under Fasting Conditions.
An open label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07098585
- Testing
- Lisdexamfetamine capsule, Elvanse® (Lisdexamfetamine dimesylate capsules, hard)
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Normal Healthy Subjects
An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different liposomal amphotericin B injections after single IV infusion at the same dose in normal healthy subjects.
- Trial name
- NCT01652859
- Testing
- Liposomal Amphotericin B, AmBisome
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Taiwan Liposome Company
Influenza, Respiratory Viral Infection
Pharmacokinetics and Bioequivalence of XC8 10 mg and 40 mg Tablets in Fasted Volunteers
Comparative study of the pharmacokinetics of XC8, film-coated tablets, 10 mg and XC8, film-coated tablets, 40 mg, when administered once in equal doses (40 mg) on an empty stomach in healthy volunteers.
- Trial name
- NCT05558462
- Testing
- XC8
- Where
- Russia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
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