Clinical trials: Bioequivalence
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
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
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
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
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
Otitis Media in Patients With Tympanostomy Tubes
Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX®…
- Trial name
- NCT01994642
- Testing
- Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension, CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
- Where
- 23 sites in United States
- Volunteers
- 203 people
- Sponsor
- Par Pharmaceutical, 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
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
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.
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
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
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
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
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
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
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 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
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.
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