Clinical trials: Bioequivalence
Acne
Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the…
- Trial name
- NCT02249767
- Testing
- Tretinoin
- Volunteers
- 574 people, healthy volunteers welcome
- Sponsor
- Spear Pharmaceuticals
Congenital Hypothyroidism, Hypothyroidism
Generic vs. Name-Brand Levothyroxine
This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this.
- Trial name
- NCT00403390
- Testing
- Brand Name Levothyroxine (Synthroid), Generic formulation of Levothyroxine
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Scabies
A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies
This phase III study was conducted to establish the clinical bioequivalence of Permethrin Cream 5% and Elimite™ in the treatment of scabies following a single application.
- Trial name
- NCT03973775
- Testing
- Permethrin Cream 5%
- Where
- 5 sites in United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Saptalis Pharmaceuticals LLC
Healthy
A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the safety and pharmacokinetics after co-administration of CTL0201 and CTL0202 or administration of CT-L02 in healthy volunteers.
- Trial name
- NCT07128654
- Testing
- CTL02, CTL0201, CTL0202
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Celltrion
Acne
Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
- Trial name
- NCT01243450
- Testing
- Tretinoin
- Where
- United States
- Volunteers
- 958 people, healthy volunteers welcome
- Sponsor
- Spear Pharmaceuticals
Healthy
Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers
Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850 mg administered together
- Trial name
- NCT02220647
- Testing
- Linagliptin/Metformin FDC, Linagliptin, Metformin
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.
- Trial name
- NCT00649493
- Testing
- Rabeprazole Sodium Tablets 20 mg, Aciphex® Tablets 20 mg
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Head Lice
Bioequivalence Study for Benzyl Alcohol Lotion 5%.
To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5% with Ulesfia Lotion 5% in eradication of head lice in the study subjects.
- Trial name
- NCT02624843
- Testing
- Benzyl Alcohol Lotion 5%, Ulesfia (benzyl alcohol lotion) 5%
- Where
- 4 sites in United States
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Akorn, Inc.
Acne Vulgaris
Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris
- Trial name
- NCT02616614
- Testing
- Onexton, Clindamycin/benzoyl peroxide gel
- Where
- 17 sites in United States
- Volunteers
- 862 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Atopic Dermatitis
Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis
The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to…
- Trial name
- NCT02791308
- Testing
- Pimecrolimus Cream 1% (Valeant), Vehicle cream, Pimecrolimus Cream, 1%
- Where
- 53 sites in United States
- Volunteers
- 587 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Acne
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
- Trial name
- NCT01135069
- Testing
- Tretinoin microsphere 0.1%, Brand Retin-A Micro tretinoin microsphere gel 0.1%
- Where
- United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Spear Pharmaceuticals
Healthy Men and Women
Open-label Study Using 50 Mg Liquid Etanercept Subcutaneous Injection in the Thigh to Compare an Auto-injector Device and a Manual Injection in Healthy Subjects
A single-center, open-label, randomized study with a screening period of up to 21 days. Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the thigh to compare injection by auto-injection…
- Trial name
- NCT02588534
- Testing
- etanercept (ENBREL®) via auto-injector device, Etanercept (ENBREL®) via Manual injection
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Amgen