Clinical trials: Bioequivalence
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.
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.
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
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
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
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
Epilepsy
Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients
The retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in…
- Trial name
- NCT04132063
- Testing
- Generic levetiracetam
- Where
- Thailand
- Volunteers
- 75 people
- Sponsor
- Mahidol University
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
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.
Malaria
Mefloquine Bioequivalence Among 3 Commercially Available Tablets.
The objective of this study was to determine the bioequivalence among three commercial tablet formulations of MQ, i.e. Lariam, Mephaquin, and Mefloquine-(AC Farma) when given in combination with artesunate.
- Trial name
- NCT00544024
- Where
- Peru
- Volunteers
- 39 people
- Sponsor
- Centers for Disease Control and Prevention
Vulvar Atrophy, Vaginal Atrophy
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol. The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is…
- Trial name
- NCT01753102
- Testing
- Estradiol
- Where
- India
- Volunteers
- 49 people
- Sponsor
- Sun Pharmaceutical Industries Limited
HIV Infections
Bioequivalence Study of Didanosine in Children Treated for HIV
The purpose of this study is to show that the administration of 400/mg/m2/day of didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of didanosine during fasting, in HIV infected children…
- Trial name
- ddI (NCT00668356)
- Testing
- didanosine
- Where
- France
- Volunteers
- 26 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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.
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
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
Seasonal Allergic Rhinitis
Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation
The objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd.
- Trial name
- NCT01523236
- Testing
- Mometasone furoate, Nasonex®
- Volunteers
- 800 people
- Sponsor
- Teva Pharmaceuticals USA
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
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
Asthma
A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg 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 and…
- Trial name
- NCT03676413
- Testing
- Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals, ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
- Where
- Greece
- Volunteers
- 451 people
- Sponsor
- Respirent Pharmaceuticals Co Ltd.