Clinical trials: Bioequivalence Study
Healthy
Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under…
- Trial name
- NCT00649129
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04406194)
- Testing
- FAVICOVIR 200 mg Film Tablet, AVIGAN 200 mg Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atabay Kimya Sanayi Ticaret A.S.
Bioequivalence, Healthy Volunteers
A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms
This is a single-dose, randomized, two-period cross-over study with 72 healthy male and female volunteers. The investigational products will be given (after fasting overnight) at separate visits separated by 7 ± 3 days.
- Trial name
- NCT03213353
- Testing
- Tablet paracetamol, guaifenesin and phenylephrine HCL, Vicks Active SymptoMax Plus powder for oral solution
- Where
- Russia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
Healthy
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in…
- Trial name
- NCT01947153
- Testing
- Metformin, Linagliptin
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bioequivalence, Healthy Japanese Subjects
Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects
This study will be an open-label, randomised, three-period, three-treatment, crossover study in healthy Japanese male and female of non-childbearing potential subjects, performed at a single study centre.
- Conditions
- Bioequivalence, Healthy Japanese Subjects, Pharmacokinetics
- Trial name
- NCT02436577
- Testing
- Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water, Ticagrelor OD tablet (90 mg single dose) administered without water, Ticagrelor IR tablet (90 mg) administered with 150 mL of water
- Where
- United Kingdom
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence
Bioequivalence Study of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® 75 mg Tablet After Oral Administration to Healthy Adult Subjects Under Fasting Condition
To compare the rate and extent of absorption of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® (clopidogrel) 75 mg tablet under fasting condition.
- Trial name
- NCT05186129
- Testing
- Clopid® 75 mg Tablet, Plavix® 75mg Tablet
- Where
- Pakistan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Center for Bioequivalence Studies and Clinical Research
Healthy
An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule
The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the…
- Trial name
- NCT01009541
- Testing
- Pregabalin controlled release, 82.5 mg, Pregabalin controlled release, 165 mg, Pregabalin controlled release, 330 mg
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Gastrointestinal Diseases
A Bioequivalence Study of Idiazole 20mg DR Tabs and PARIET® 20 mg DR Tabs After a Single Oral Dose Administration Under Fasting Conditions in Healthy Adults
This is an open-label, randomized, single dose, two-sequence, two-period crossover study, separated by 7 days washout interval from the first study drug administration.
- Trial name
- NCT02446483
- Testing
- Idiazole 20mg DR tabs, PARIET 20 mg DR tabs
- Where
- Egypt
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus(T2DM)
A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration
The primary objective of this study is to assess the pharmacokinetic parameters of saxagliptin and metformin in healthy male Chinese subjects.
- Trial name
- SAXA (NCT01755494)
- Testing
- Saxagliptin 5 mg, Metformin XR 500 mg, Mertformin XR 2 x 500 mg
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in…
- Trial name
- NCT01132183
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Fasting Conditions
This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co.
- Trial name
- NCT01188031
- Testing
- ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG, NIRAVAM TM 2 mg orally disintegrating tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of Ranbaxy amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one4ablet dose in fasted subjects.
- Trial name
- NCT00775905
- Testing
- amlodipine 10 mg tablet
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual…
- Trial name
- NCT03629054
- Testing
- Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination), Empagliflozin, Linagliptin
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy, Plasma Concentration of YM060
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet
A study to compare time-course changes of plasma concentration of YM060 after intake of conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be administered without water.
- Trial name
- NCT01392794
- Testing
- YM060
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Hypertension
A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323
This study is required to confirm the suitability of a candidate FDC of 16mg candesartan cilexetil/12.5mg HCTZ (GSK587323) formulation for further development and provide data to allow the design of a future pivotal…
- Trial name
- NCT02094924
- Testing
- GSK587323, FDC of candesartan cilexetil 16 mg and HCTZ 12.5mg
- Where
- India
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Ribavirin 200 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of ribavirin 200 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00835146
- Testing
- Ribavirin 200 mg tablets, COPEGUS™
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Fed Conditions, Healthy Volunteer
A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal
Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers
- Trial name
- NCT07333742
- Testing
- Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy Volunteers
Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in…
- Trial name
- NCT01394224
- Testing
- Levetiracetam
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Healthy
Fasting Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg
The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered…
- Trial name
- NCT00649662
- Testing
- Ciprofloxacin Extended-Release Tablets 1000 mg, Cipro® XR Tablets 1000 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Infections, Bacterial
Amoxicillin Bioequivalence Study Brazil - Fast
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the…
- Trial name
- NCT01431989
- Testing
- Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL, Amoxil® 500mg/5mL powder for oral suspension
- Where
- Brazil
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline