Clinical trials: Therapeutic Equivalency
Type 2 Diabetes
Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and…
- Trial name
- NCT01093794
- Testing
- Co-administration of 50 mg sitagliptin and 500 mg metformin, sitagliptin/metformin 50 mg/500 mg tablet, Co-administration of 50 mg sitagliptin and 850 mg metformin
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Anxiety Disorders
Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have been approved for the treatment of three anxiety indications in China.
- Trial name
- NCT03329573
- Testing
- Paroxetine IR tablets A, Paroxetine IR tablets B
- Where
- China
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and…
- Trial name
- NCT00966641
- Testing
- Naproxen, PL 3100
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- PLx Pharma
Healthy
Bioequivalence Study of Valsartan 320mg Tablets Under Fed Conditions
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence, single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg under fed conditions.
- Trial name
- NCT02197494
- Testing
- Valsartan
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir
Bioequivalence study of two formulations containing a fixed dose combination of 600 mg Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets under a single-dose, two-way crossover design.
- Trial name
- NCT03309566
- Testing
- Efavirenz, tenofovir disoproxil fumarate and emtricitabine
- Where
- Argentina
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorio Elea Phoenix S.A.
Healthy
A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co.
- Trial name
- NCT00865241
- Testing
- Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg, CLUCOVANCE® 5 mg/500 mg Tablets, single dose
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence of Bicalutamide New Formulation in Japan
The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects
- Trial name
- NCT01416870
- Testing
- ICI176,334-1, Casodex 80 mg tablet
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
The purpose of this study was to evaluate the relative bioavailability of a test formulation of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals, USA) compared to the reference listed…
- Trial name
- NCT01344369
- Testing
- Norethindrone/Ethinyl Estradiol, FEMCON® Fe
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Zolpidem 10 mg Tablets Under Fed Conditions
The study compared the relative bioavailability (rate and extent of absorption) of 10 mg Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by Sanofi-Synthelabo, Inc.
- Trial name
- NCT00779441
- Testing
- Zolpidem 10mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.
- Trial name
- NCT00648388
- Testing
- Cilostazol Tablets 100 mg, Pletal® Tablets 100 mg
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
To Determine Bioequivalence Under Fed Conditions
The Study Aims to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Assessed.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 850/50 mg manufactured by Oman Pharmaceuticals Products Co.
- Trial name
- NCT05337969
- Testing
- Metformin and Vildagliptin 850/50 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AET Laboratories Private Limited
Healthy
Cefprozil 500 mg Tablets Under Fed Conditions
The objective of this study is to compare the relative bioavailability of cefprozil 500 mg tablets with that of Cefzil 500 mg tablets in healthy, non-smoking adults under non-fasting conditions.
- Trial name
- NCT00840866
- Testing
- cefprozil, Cefzil®
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Hypertension
Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components
This study will be a randomized study investigating the bioequivalence of COREG CR and Lisinopril to COREG CR and ZESTRIL
- Trial name
- NCT00556920
- Testing
- COREG CR
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition
This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in…
- Trial name
- NCT02296723
- Testing
- Valganciclovir Hydrochloride
- Where
- India
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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.
Healthy
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and…
- Trial name
- NCT02084082
- Testing
- Linagliptin/Metformin ER FDC, Linagliptin, Metformin ER
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Fed Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.
- Trial name
- NCT00650013
- Testing
- Midodrine HCl Tablets 5 mg, ProAmatine® Tablets 5 mg
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions
The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran ODT under fasting conditions in healthy, non-smoking adult…
- Trial name
- NCT00934180
- Testing
- Ondansetron, Zofran®
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Fasting
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fed Condition
The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fed condition.
- Trial name
- NCT01831674
- Testing
- Metformin Hydrochloride Extended-Release Tablets USP 750, GLUCOPHAGE®XR tablet 750 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the…
- Trial name
- NCT01157182
- Testing
- Estradiol/Norethindrone acetate, Activella®
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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