Clinical trials: Therapeutic Equivalency
Healthy
Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.
- Trial name
- NCT01027689
- Testing
- alprazolam commercial immediate release oral tablet, alprazolam test sublingual tablet
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
A Relative Bioavailability Study of 60 mg Nifedipine Extended Release Tablets Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability of Nifedipine ER tablets 60 mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg by Bayer Pharmaceuticals Corporation, Bayer…
- Trial name
- NCT00865891
- Testing
- Nifedipine Extended Release tablets 60 mg, single dose, ADALAT® CC Extended Release Tablets 60 mg
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Glaucoma, Primary Open Angle, Ocular Hypertension
Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
The purpose of this study is to compare the efficacy and tolerance of generic travoprost with its brand name formulation. In this open label, randomized, crossover study, the primary outcome will be intraocular pressure and the…
- Trial name
- NCT02796560
- Testing
- Brand name travoprost, Generic travoprost
- Where
- Canada
- Volunteers
- 76 people
- Sponsor
- Université de Sherbrooke
Healthy
The Bioequivalence of Atripla in an Oral Liquid Formulation Compared With the Tablet Formulation in Healthy Volunteers
The primary objective of this study is to determine the average bioequivalence of tenofovir, emtricitabine and efavirenz in an extemporaneously prepared oral liquid formulation (test formulation) compared with the commercially…
- Trial name
- NCT00862823
- Testing
- tenofovir, emtricitabine and efavirenz fixed dose tablet, tenofovir, emtricitabine and efavirenz tablet added to solution
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Healthy
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following…
- Trial name
- NCT00647842
- Testing
- Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay, Fentanyl Transdermal System 25 mcg/h
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bipolar I Disorder
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fed conditions.
- Trial name
- NCT01570894
- Testing
- Quetiapine Fumarate
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy
Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting Conditions
The objective of this study was to compare and evaluate the single-dose oral bioavailability of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr.
- Trial name
- NCT01267396
- Testing
- Sertraline
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Osteoporosis
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout…
- Trial name
- NCT00846196
- Testing
- risedronate DR (Phase III clinical supply), risedronate 35 mg DR (Commercial Tablet)
- Where
- 6 sites in United States
- Volunteers
- 538 people, healthy volunteers welcome
- Sponsor
- Warner Chilcott
Healthy
Deflox Tablets Bioequivalence (BE) Trial
The purpose of this study was to demonstrate the bioequivalence of Deflox® 50 milligrams (mg) tablets compared with Cataflam® DD tablets 50 mg administered as single dose in fasting conditions to healthy participants.
- Trial name
- NCT04132583
- Testing
- Deflox®, Cataflam DD®
- Where
- Mexico
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Pharmacokinetic Study
Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each period.
- Trial name
- NCT01714856
- Testing
- Ropinirole hydrochloride CR 2mg Tablets
- Where
- India
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lupin Ltd.
Healthy
A Relative Bioavailability Study of Ramipril 10 mg Capsules Administered Orally as a Sprinkle on Applesauce
To compare the rate of absorption and oral bioavailability of a test formulation of Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product…
- Trial name
- NCT00863915
- Testing
- Ramipril10 mg Capsules, single dose, Atlace® 10 mg capsules, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Bioequivalence, Adhesion
Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects
This study was intended to demonstrate bioequivalence of the Amarin's Rotigotine patch respect to Neupro, (RLD), as well as non-inferiority in adhesion, when tested at a dose of 2 mg/24h in healthy subjects of both sexes.
- Conditions
- Bioequivalence, Adhesion, Adverse Effects
- Trial name
- No acronyms (NCT07769359)
- Testing
- Rotigotine Transdermal Delivery System (TDS)
- Where
- India
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Amarin Technologies S.A.U.
Healthy
Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of Dr. Reddy's and Fosamax Tablets 70 mg of Merck \& Co.
- Trial name
- NCT01133496
- Testing
- Alendronate Sodium Tablets, 70 mg
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Bioequivalence Study of Valsartan / Amlodipine From Valsartan and Amlodipine Tablets (Hua Yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerland)
Comparative randomized, single dose, three periods, three-way crossover open-label study to determine the bioequivalence of Valsartan and Amlodipine Tablets (Hua yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine…
- Trial name
- ABSVAFVATVAT (NCT04085627)
- Testing
- Valsartan and Amlodipine Tablets
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Healthy
Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of Moexipril HCl/hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets…
- Trial name
- NCT00835042
- Testing
- Moexipril HCl/hydrochlorothiazide 15/25 mg tablets, UNIRETIC® 15/25 mg tablets
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Subjects
Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects
The goal of this clinical trial is to evaluate whether Insulex® R demonstrates similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy…
- Trial name
- NCT07364669
- Testing
- Insulex® R (soluble human insulin, biosimilar), Humulin® R (soluble human insulin, biosimilar)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Laboratorios Pisa S.A. de C.V.
Anxiety Disorders
Bioequivalence Trial of Alprazolam 0.5 mg Tablets
The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. Test product was Zamoprax® 0.5 mg (GlaxoSmithKline) and reference product Tafil® 0.5 mg (Pharmacia \& Upjohn).
- Trial name
- NCT01745562
- Testing
- Alprazolam 0.5 mg
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HCV
Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet
Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor…
- Trial name
- CRUSADE-1 (NCT03389061)
- Testing
- sofosbuvir/velpatasvir tablet, sofosbuvir/velpatasvir crushed
- Where
- 3 sites in Germany, Netherlands
- Sponsor
- Radboud University Medical Center
Bioequivalence
Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each…
- Trial name
- NCT03799536
- Testing
- Sotalol, Sotalex
- Where
- Belarus
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
HIV
Bioequivalence of Crushed Stribild With a Normal Breakfast or With Drip Feed Compared to the Whole Tablet
Elvitegravir is an HIV-1 integrase inhibitor which is marketed in a fixed dose combination tablet with cobicistat, tenofovir and emtricitabine (Stribild®, referred to as STB).
- Trial name
- CRUSTRI (NCT02325934)
- Testing
- Stribild, Stribild, crushed
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
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