Clinical trials: Bioequivalence Study
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.
Primary Immune Deficiency Disorders, Common Variable Immunodeficiency
Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of…
- Conditions
- Primary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinaemia, Hyper-IgM Syndrome
- Trial name
- GMX07 (NCT01963143)
- Testing
- Gammaplex (5%), Gammaplex 10
- Where
- 17 sites in United States, Hungary and 1 more
- Volunteers
- 48 people
- Sponsor
- Bio Products Laboratory
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
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
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
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
Acne Vulgaris
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris
- Trial name
- NCT03393494
- Testing
- Adapalene and Benzoyl Peroxide Topical Gel, Epiduo Topical Product
- Where
- United States
- Volunteers
- 825 people
- Sponsor
- Padagis LLC
Head Lice
A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice
This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.
- Trial name
- NCT03337490
- Testing
- Ivermectin 0.5% Topical Application Lotion, Ivermectin 0.5% Topical Application Lotion [SKLICE]
- Where
- 6 sites in United States
- Volunteers
- 296 people
- Sponsor
- Mayne Pharma International Pty Ltd
Seasonal Allergic Rhinitis
Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the…
- Trial name
- NCT02246920
- Testing
- Fluticasone propionate, Flonase®
- Where
- United States
- Volunteers
- 1,474 people
- Sponsor
- Teva Pharmaceuticals USA
Acne Vulgaris
Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion…
- Trial name
- NCT03717506
- Testing
- GDC 268 Lotion, Clindamycin Phosphate Lotion 1%, GDC Vehicle Lotion
- Where
- 34 sites in United States
- Volunteers
- 1,236 people
- Sponsor
- Balmoral Medical company
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 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
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.
- Trial name
- NCT03107611
- Testing
- Pimecrolimus Cream, 1%
- Where
- 27 sites in United States, Dominican Republic and 1 more
- Volunteers
- 654 people
- Sponsor
- Mylan 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.