Clinical trials: Bioequivalence Study
Healthy
Ursodiol 500 mg Tablets Under Fed Conditions
The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference)after a single-dose in healthy subjects under fed conditions.
- Trial name
- NCT00909753
- Testing
- Ursodiol, Urso Forte™
- Where
- Canada
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Comparative Bioavailability Study of Lisinopril Tablets, 10 mg
The purpose of this study is to compare the bioavailability of Par Lisinopril 10 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).
- Trial name
- NCT01375244
- Testing
- Lisinopril, Zestril
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Infections, Respiratory Tract
Bioequivalence Study of Cephalexin Suspension 125
The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent. Test product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5…
- Trial name
- NCT01767532
- Testing
- Cephalexin 125 mg/5ml
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
- Trial name
- NCT00939367
- Testing
- Zolpidem Tartrate Tablets 10 mg, 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Infections, Respiratory Tract
Bioequivalence Study of Cephalexin Suspension 250
The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent. Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5…
- Trial name
- NCT01767571
- Testing
- Cephalexin 125 mg/5ml, Cephalexin 250mg/5ml
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
Study Design : A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study
- Trial name
- NCT01197014
- Testing
- Amlodipine plus Losartan, Amlodipine, Losartan
- Where
- Czechia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Female Contraception
Bioequivalence Study of Patches With Different Release Profiles
The purpose of this study was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.
- Trial name
- NCT00697307
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Fed
Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition
Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.
- Trial name
- NCT01372306
- Testing
- Reminyl
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Bioavailability Of Lersivirine Single 750 Mg Tablet Versus 3 X 250 Mg Tablets
This is a randomized study to assess whether the pharmacokinetics of a new single 750 mg tablet is similar to 3 x 250 mg tablets (750 mg total).
- Trial name
- NCT01050751
- Testing
- Lersivirine
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions
The purpose of this study is to investigate the release of memantine into the bloodstream of two different formulations: one formulation containing lactose and one without lactose.
- Trial name
- NCT03670095
- Testing
- Lactose-free memantine, Memantine
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Chronic Graft Versus Host Disease
Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants
The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants…
- Trial name
- NCT07726914
- Testing
- Belumosudil
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type2 Diabetes
A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fasting State
A study demonstrates the bioequivalence of DA-1229_01(A) at Fasting State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults
- Trial name
- NCT03939143
- Testing
- DA-1229_01(A), Sugamet SR Tab 5/1000mg®, Sugamet SR Tab 5/1000mg®, DA-1229_01(A)
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Japanese Healthy Adult Male
A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20 milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg…
- Trial name
- NCT03808493
- Testing
- TAK-438 OD, TAK-438
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg
The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5 mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x 12.5 mg) dose administered under fasting conditions.
- Trial name
- NCT00650416
- Testing
- Carvedilol Tablets 12.5 mg, Coreg® Tablets 12.5 mg
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Invasive Fungal Infections
A Bioequivalence Study of APX001 High-load and Low-load Tablets
A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.
- Trial name
- NCT05491733
- Testing
- APX001, APX001A
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Healthy
Bioequivalence of Telmisartan / HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers
To establish the bioequivalence of fixed dose combination of 40 mg telmisartan / 12.5 mg HCTZ vs. its monocomponents
- Trial name
- NCT02262598
- Testing
- Telmisartan, Hydrochlorthiazide (HCTZ), Telmisartan/HCTZ fixed dose
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom)
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Elbanovir 400 mg Film Coated Tablets ( Multi-Apex…
- Trial name
- NCT02605798
- Testing
- Elbanovir, Sovaldi
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fed Conditions
This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single dose, crossover fully replicated study was conducted on fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of…
- Trial name
- NCT00872235
- Testing
- fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Participants
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
- Trial name
- NCT05048784
- Testing
- Sotorasib
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy
Bioequivalence Study of Sumatriptan 100mg Tablets Under Fed Conditions
To access the single-dose oral bioequivalence of sumatriptan succinate 100 mg tablet (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of OHM Laboratories Inc.
- Trial name
- NCT00872274
- Testing
- sumatriptan 100mg
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited