Clinical trials: Bioequivalence
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
Acne Vulgaris
Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel…
- Trial name
- NCT03522441
- Testing
- Clindamycin 1% Gel
- Where
- 12 sites in United States, Belize
- Volunteers
- 1,125 people
- Sponsor
- Akorn, Inc.
Seasonal Allergic Rhinitis
A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR)
The objectives of this study is to demonstrate bioequivalence (comparable safety and efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic rhinitis.
- Trial name
- NCT01673659
- Testing
- Mometasone furoate, Nasonex Nasal Spray
- Where
- United States
- Volunteers
- 1,220 people
- Sponsor
- Padagis LLC
Attention Deficit Hyperactivity Disorder
Pharmacokinetics of Two Extended-Release Formulations of Methylphenidate in Children With Attention Deficit Hyperactivity Disorder (ADHD)
This study is designed to provide pharmacokinetic data for the assessment of bioequivalence of Ritalin LA formulation compared to Medikinet ret. concerning plasma levels and efficacy measures.
- Trial name
- MPH-Kinetics (NCT00772161)
- Testing
- Methylphenidate
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- University Hospital Freiburg
Acne
Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris
The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to an FDA approved product for the treatment acne vulgaris.
- Trial name
- NCT02525549
- Testing
- Adapalene and Benzoyl Peroxide Gel, Adapalene and Benzoyl Peroxide Gel (Reference)
- Volunteers
- 903 people
- Sponsor
- Padagis LLC
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
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.
Plaque Psoriasis
Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis
To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis
- Trial name
- NCT05763082
- Testing
- roflumilast cream 0.3%, Zoryve
- Where
- United States
- Volunteers
- 416 people
- Sponsor
- Padagis LLC