Clinical trials: Bioequivalence Study in Healthy Subjects
Gastroduodenal Ulcer
BE Study of Gaster®D Tab 20mg (Manufacturer Changed)
An Open-Label, Randomized, Two-sequence, Two-period, Fasting Condition, Single Oral Dose, Cross-over Study of Bioequivalence of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" and "Gaster®D Tab 20mg (Famotidine) (Unchanged…
- Trial name
- NCT04123899
- Testing
- IGAD→GSTD, GSTD→IGAD
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy
Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fasting conditions.
- Trial name
- NCT01124162
- Testing
- Losartan, Cozaar®
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Relative Bioavailability Study of Cetirizine HCl 10 mg Tablets Under Fasting Conditions
To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations after administration of single doses to normal healthy subjects under fasted conditions.
- Trial name
- NCT00864279
- Testing
- Cetirizine Hydrochloride 10 mg tablets, single dose, Zyrtec® 10 mg tablets, single dose
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a single, oral 75 mg (1 x 75 mg) dose administered…
- Trial name
- NCT00650169
- Testing
- Clopidogrel Bisulfate Tablets 75 mg, Plavix® Tablets 75 mg
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers, Male
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin 0.4 mg Tablets, in Healthy Adult Male Subjects, Under Fed Conditions
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0,4 mg…
- Trial name
- NCT07091669
- Testing
- Tamsulosin (0.4 mg/j)
- Where
- Armenia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
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
Psoriasis
Bioequivalence Test of Hemay005 Tablets
The pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations.
- Trial name
- NCT06610903
- Testing
- Hemay005
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
Healthy
Fasting Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt extended release test capsule formulation of chlorpheniramine polistirex/hydrocodone…
- Trial name
- NCT00853294
- Testing
- Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule, 5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy
Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule under fasting conditions.
- Trial name
- NCT00836056
- Testing
- Clindamycin 300 mg capsule, Cleocin HCl 300 mg capsules
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Cardiomyopathy
A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
- Trial name
- NCT07479641
- Testing
- Test formulation of HRS-1893 tablet, Reference formulation of HRS-1893 tablet
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Pharmacokinetic Study
Two Way Cross Over BE Fasting Pilot Study of Ropinirole Hydrochloride CR 2mg Tablets
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 24 hours post-dose in each period.
- Trial name
- NCT01712568
- Testing
- Test Product (Ropinirole), Reference Product (REQUIP )
- Where
- India
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lupin Ltd.
Bioequivalence, Diabetes Mellitus, Type 2
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose…
- Trial name
- NCT06124560
- Testing
- Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Healthy
Fasting Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg
The objective of this study was to investigate the bioequivalence of Mylan's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under…
- Trial name
- NCT00649779
- Testing
- albuterol sulfate extended-release 8 mg tablets, VoSpire™ ER 8 mg tablets
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions
A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.
- Trial name
- NCT02041273
- Testing
- palbociclib isethionate (phase 1 and 2 studies), palbociclib commercial free base capsule
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Erectile Dysfunction
Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.
The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil…
- Trial name
- NCT06782659
- Testing
- ASP-001, Viagra
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Aspargo Labs, Inc
Fed
Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01618760
- Testing
- Risperidone Tablet 1 mg, Risperidone
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Type 2 Diabetes Mellitus
Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg…
- Trial name
- NCT02060201
- Testing
- Saxagliptin, Dapagliflozin, Saxagliptin/Dapagliflozin FDC
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Esomeprazole Bioavailability Study With 40 mg Oral Single Dose Fasted and Fed Administration
The present study will be conducted in order to compare the bioavailability of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) and of INexium 40 mg MUPS tablets (AstraZeneca, France) under single dose fasted and fed…
- Trial name
- NCT00889850
- Testing
- 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland), INexium 40 mg MUPS tablets (AstraZeneca, France)
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Mepha Ltd.
Acute Lymphoblastic Leukemia
Bioequivalence of An Oral Mercaptopurine Suspension 100 Mg / 5 Ml Versus Tablet in Healthy Male Subjects Under Fasting Conditions
The primary objective of this study is to determine whether the test product, mercaptopurine oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are bioequivalent.
- Trial name
- NCT01697020
- Testing
- Mercaptopurine 20mg/ml oral suspension, Mercaptopurine 50mg tablet
- Where
- South Africa
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Nova Laboratories Limited
Healthy Volunteers
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fasting Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080482
- Testing
- Tacrolimus 5 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
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