Clinical trials: Therapeutic Equivalency
- Condition Therapeutic Equivalency
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
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
Atopic Dermatitis
Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis
A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1% and Reference Listed Elidel® (Pimecrolimus…
- Trial name
- NCT03297502
- Testing
- pimecrolimus cream 1%, Elidel (pimecrolimus) cream 1%
- Volunteers
- 582 people
- Sponsor
- Par Pharmaceutical, Inc.
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
Healthy
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions
Objective: To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions.
- Trial name
- NCT00946036
- Testing
- Sertraline Hydrochloride
- Where
- Canada
- Sponsor
- Torrent Pharmaceuticals Limited
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
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
Acne Vulgaris
Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%
To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products…
- Trial name
- NCT04329403
- Testing
- Adapalene 0.1% Gel, Differin 0.1% Topical Gel
- Sponsor
- Aurobindo Pharma Ltd
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 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.
Rhinitis, Allergic, Perennial
Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray (Study P04419)
This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of solution per spray) to the new formulation…
- Trial name
- NCT00779740
- Testing
- mometasone furoate
- Volunteers
- 102 people
- Sponsor
- Organon and Co
Secondarily Infected Traumatic Skin Lesions
A Study to Evaluate the Safety and Bioequivalence of Mupirocin Calcium Cream, 2% and Bactroban® Cream and Compare Both to a Vehicle in Treatment of Secondarily Infected Traumatic Skin Lesions.
The primary objective of this study is to determine the comparability of the safety and efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily infected traumatic skin lesions.
- Trial name
- NCT01876550
- Testing
- Mupirocin Calcium Cream, 2%, Bactroban® Cream, Cream vehicle of test product
- Volunteers
- 1,902 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
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
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
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
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
Acne Vulgaris
A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris
EPIDUO™ (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, marketed by GALDERMA LABORATORIES, L.P., is a safe and effective topical therapy used for the treatment of acne vulgaris.
- Trial name
- NCT01501799
- Testing
- adapalene 0.1% and benzoyl peroxide 2.5% topical gel, EPIDUO
- Where
- 25 sites in United States, Belize and 1 more
- Volunteers
- 885 people
- Sponsor
- Actavis Mid-Atlantic LLC
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
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