Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy Subjects
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233162
- Testing
- Febuxostat-Test product, Febuxostat-Reference product
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg
The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fasting…
- Trial name
- NCT00650273
- Testing
- Azithromycin Tablets 600 mg, Zithromax® Tablets 600 mg
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fasting Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080456
- Testing
- Tacrolimus 1 mg capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Drug Use
Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject
The study was conducted to investigate whether 20 mg omeprazole capsules manufactured by PT. Dankos Farma for PT. Hexpharm Jaya is bioequivalent to its reference product, 20 mg Losec® capsules manufactured by AstraZeneca AB…
- Trial name
- NCT05849883
- Testing
- Omeprazole 20 mg Capsules
- Where
- Indonesia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- PT Kalbe Farma Tbk
Healthy
A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers
The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2 sprinkle capsule formulations of rabeprazole sodium when administered without food to healthy volunteers.
- Trial name
- NCT01241409
- Testing
- Rabeprazole sodium: Treatment A, Rabeprazole sodium: Treatment B, Rabeprazole sodium: Treatment C
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
Food Study of Pioglitazone HCl Tablets 45 mg to Actos® Tablets 45 mg
The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl 45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose administration under fed conditions.
- Trial name
- NCT00649012
- Testing
- Pioglitazone HCl Tablets 45 mg, Actos® Tablets 45 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01671709
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union).
- Trial name
- NCT01844804
- Testing
- PF-06438179, Remicade
- Where
- United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets
The sponsor, Pfizer has developed a formulation of tramadol hydrochloride/ paracetamol 37.5 mg/ 325 mg (test drug) as a generic alternative to the reference listed product Ultracet®.
- Trial name
- NCT03803371
- Testing
- Ultracet Tablets, Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
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.
Healthy Volunteer
Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions
- Trial name
- NCT06308068
- Testing
- Diacerein 50 mg Capsule
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- International Bio service
Drug Use
Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects
The study was conducted toinvestigate whether the bioavailability of 3 mg Glimepiride Tablet Manufactured by PT. Harsen Laboratories was bioequivalent to the reference product, 3 mg Amaryl® Tablet Manufactured by PT.
- Trial name
- NCT05468879
- Testing
- Glimepiride, Amaryl®
- Where
- Indonesia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- PT Harsen Laboratories
Healthy Participants
A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation…
- Trial name
- NCT01619527
- Testing
- darunavir, cobicistat
- Where
- Belgium
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Healthy
A Study of Abemaciclib in Healthy Participants
The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s).
- Trial name
- NCT02672423
- Testing
- Abemaciclib Capsules (Reference Formulation), Abemaciclib Tablet (Test Formulation)
- Where
- 2 sites in United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01888263
- Testing
- Lamotrigine
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet coadministered with canagliflozin in healthy…
- Trial name
- NCT02865668
- Testing
- Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Canagliflozin, Metformin Extended Release (XR)
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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
Healthy
Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans
Two formulations containing the same active pharmaceutical ingredient are considered bioequivalent if their relative bioavailability (rate and extent of drug absorption) falls within acceptable predetermined limits after…
- Trial name
- NCT07331194
- Testing
- HMPL-523 Acetate Tablets (Test Formulation), HMPL-523 Acetate Tablets (Reference Formulation)
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Healthy
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions
This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT03696329
- Testing
- Tetrabenazine Tablets 25 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Parkinson Disease
Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone
The purpose of this study is to evaluate the bioavailability and the bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (25 mg and 50 mg) after a single…
- Trial name
- NCT03116295
- Testing
- Opicapone (OPC)
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.