Clinical trials: Bioequivalence
- Condition Bioequivalence
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
Severe Hemophilia A
rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study
The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve…
- Trial name
- NCT06137092
- Testing
- Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)
- Where
- 5 sites in Iran
- Volunteers
- 50 people
- Sponsor
- AryoGen Pharmed Co.
Hemophilia A
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate…
- Trial name
- NCT00141843
- Testing
- ReFacto AF, B-Domain deleted Recombinant Factor VIII, BDDrFVIII
- Where
- 41 sites in United States, Australia and 11 more
- Volunteers
- 100 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Acne Vulgaris
Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris
The objective of this study was to evaluate the efficacy and safety of the test formulation of adapalene gel 0.1% (PLIVA Research \& Development Ltd.) as compared to the already marketed formulation, Differin® (adapalene 0.1%)…
- Trial name
- NCT01182636
- Testing
- Adapalene, Differin®
- Where
- 22 sites in United States, Belize
- Volunteers
- 601 people
- Sponsor
- Teva Pharmaceuticals USA
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
MILD TO SEVERE ACNE VULGARIS
Bioequivalence Study Comparing Clindamycin Phosphate (1.2%) and Tretinoin (0.025%) Topical Gel to Ziana and Placebo
ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) gel, marketed by Medicis, The Dermatology Company®, is a safe and effective topical therapy used for the treatment of acne vulgaris.
- Trial name
- NCT01257906
- Testing
- CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL, ZIANA®, Vehicle Control
- Where
- India
- Volunteers
- 1,225 people
- Sponsor
- Actavis Mid-Atlantic LLC
Cystic Fibrosis
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene.
- Trial name
- RM/NEB-03-10 (NCT01337219)
- Testing
- Tobramycin
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Erempharma
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.
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
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.
Acne Vulgaris
Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris
To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP USA) in the treatment of acne vulgaris.
- Trial name
- NCT03650361
- Testing
- Adapalene Gel 0.3%, Differin 0.3% Topical Gel
- Where
- 10 sites in United States, Belize
- Volunteers
- 755 people
- Sponsor
- Aleor Dermaceuticals Limited
Asthma
Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate
A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 µg and Salmeterol Xinafoate 50 µg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects…
- Trial name
- NCT02649478
- Testing
- Fluticasone / Salmeterol, Advair Diskus 100/50
- Where
- 100 sites in United States
- Volunteers
- 1,430 people
- Sponsor
- Roxane Laboratories
Cystic Fibrosis
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene.
- Trial name
- NCT01288170
- Testing
- Nebcinal Tobi, Tobi Nebcinal
- Where
- 2 sites in France
- Volunteers
- 12 people
- Sponsor
- Erempharma
Seasonal Allergic Rhinitis
Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™
To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of…
- Trial name
- NCT02249663
- Testing
- Azelastine hydrochloride and Fluticasone propionate, Dymista™
- Where
- United States
- Volunteers
- 1,535 people
- Sponsor
- Teva Pharmaceuticals USA
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
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.
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
Asthma
A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma
Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg/ blister…
- Trial name
- ANASSA-PD (NCT04665895)
- Testing
- Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals, FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK
- Where
- Greece
- Volunteers
- 451 people
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
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
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