Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy Volunteers
Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.
- Trial name
- NCT01055769
- Testing
- Linezolid
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Pfizer
Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis
Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray
Single dose (four sprays) bioequivalence study of Azelastine Hydrochloride/ Fluticasone Propionate 137 microgram/50 microgram Nasal Spray and 'DYMISTA' (Azelastine Hydrochloride/Fluticasone Propionate) Nasal Spray 137…
- Trial name
- NCT06180083
- Testing
- Azelastine Hydrochloride/ Fluticasone propionate nasal spray, 'DYMISTA' NASAL SPRAY
- Where
- India
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Bacterial Infection
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
- Trial name
- NCT00939562
- Testing
- doxycycline monohydrate tablet, doxycycline carragenate tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions
Study comparing 2 formulations of bosutinib in healthy subjects.
- Trial name
- NCT01080365
- Testing
- SKI-606 (Bosutinib)
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
A Bioequivalence Study of L04TD1 Compared to Administration of L04RD1 in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD1 in healthy volunteers.
- Trial name
- NCT05568121
- Testing
- L04RD1, L04TD1
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Celltrion
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
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
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 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
Metformin ER 750 mg Tablets, Fed
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fed conditions.
- Trial name
- NCT00834613
- Testing
- Glucophage® XR 750 mg Tablets, Metformin ER 750 mg Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions
The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8 mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy Pharmaceuticals, USA) with Zofran ODT® 8 mg orally…
- Trial name
- NCT01523119
- Testing
- Ondansetron
- Where
- India
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bioequivalence
A Pilot Bioequivalence Study of Pomalidomide
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
- Trial name
- NCT03424928
- Testing
- Pomalidomide 4 MG Oral Capsule, Pomalidomide 4 MG Oral Capsule-Pomalyst
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Peripheral (Sensorimotor) Diabetic Polyneuropathy
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S.
- Trial name
- NCT04214665
- Testing
- Alpha Lipoic acid 600 mg HR film coated tablets
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ilko Ilac San. ve Tic. A.S.
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