Clinical trials: Fed
Healthy
Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 mg
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam Extended-release 3 mg tablets to Pharmacia \& Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered…
- Trial name
- NCT00650299
- Testing
- Alprazolam Extended-release Tablets 3 mg, Xanax XR® Tablets 3 mg
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Leishmaniasis
Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants
This study is the first to test GSK3494245 in humans, to evaluate its safety, tolerability, and pharmacokinetics (PK) after a single dose.
- Trial name
- NCT04504435
- Testing
- GSK3494245
- Where
- United Kingdom
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 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) tablets co-administered with canagliflozin in healthy…
- Trial name
- NCT02851095
- 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
Bioequivalence Study of Amlodipine 10mg Tablets Under Fed 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, one tablet dose in fed state subjects.
- Trial name
- NCT00775151
- Testing
- amlodipine 10 mg tablet
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteers, Fasting
Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers
The goal of this clinical trial is to evaluate the pharmacokinetic profiles and bioequivalence, and to determine the safety and tolerability of the TAH3311 Oral Dissolving Film (ODF) 5mg compared with ELIQUIS® (Apixaban) 5mg Oral…
- Conditions
- Healthy Volunteers, Fasting, Fed
- Trial name
- NCT05995119
- Testing
- Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- TAHO Pharmaceuticals Ltd.
Healthy
A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets…
- Trial name
- NCT01508195
- Testing
- Canagliflozin tablets, Metformin IR tablets, Canagliflozin/metformin IR FDC tablets
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Fasting
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fed Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover, oral pivotal bioequivalence study.
- Trial name
- NCT01831687
- Testing
- Etodolac Extended Release Tablets USP 600mg, Etodolac Extended Release Tablets 600mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Atrial Fibrillation
Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103
This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103.
- Trial name
- NCT02390258
- Testing
- 10mg XEN-D0103, 30mg XEN-D0103, 60mg XEN-D0103
- Where
- United Kingdom
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Xention Ltd
Therapeutic Equivalence
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing…
- Trial name
- Morpheus PK (NCT01666678)
- Testing
- BAY98-7111, Naproxen Sodium (Aleve, BAYH6689), Diphenhydramine HCl
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Bayer
Thrombocytopenia
Bioequivalence Study of Eltrombopag Olamine Tablets in Healthy Subjects in the Fed State
The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fed conditions.
- Trial name
- NCT06768619
- Testing
- Group 1: single-dose of test formulation+single-dose of reference formulation, Group 2: single-dose of reference formulation+single-dose of test formulation
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy
Bioequivalence Study to Compare Two Formulations of Deanxit®
The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed…
- Trial name
- NCT03472651
- Testing
- test treatment: flupentixol/melitracen, reference treatment: flupentixol/melitracen
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Lamotrigine Extended-Release Tablets 50 mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01888757
- Testing
- Lamotrigine
- Where
- India
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Depression - Major Depressive Disorder
Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)
To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.
- Trial name
- NCT01190514
- Testing
- desvenlafaxine succinate sustained release
- Where
- Belgium
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Subjects
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Nebivolol 20 mg Tablet
Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic®20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.
- Trial name
- NCT03517033
- Testing
- Torrent's Nebivolol Tablets, Forest Pharmaceuticals Inc.'s Bystolic Tablets
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition
The purpose of this study is to compare the single-dose oral bioavailability of oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories, USA (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with Trileptal® 300 mg/5mL oral…
- Trial name
- NCT00951847
- Testing
- oxcarbazepine 300 mg/5 mL oral suspension
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Pharmacokinetics
Fed Bioequivalence Study of 2 Metformin 500 mg Prolongued Release Tablets in 28 Healthy Male and Female Volunteers
The objective of the study is to compare the bioavailability of the Test and Reference products both containing Metformin 500 mg prolonged release tablets (MFM) in healthy male and female volunteers under fed conditions and to…
- Trial name
- NCT05124717
- Testing
- Metformin, prolonged-release tablets 500 mg (JSC Farmak, Ukraine), Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)
- Where
- Czechia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Healthy
Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants
The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.
- Trial name
- NCT00480948
- Testing
- Infant formula feeding (InFat™), Control
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Type 2 Diabetes Mellitus
Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet…
- Trial name
- NCT01068743
- Testing
- saxagliptin, metformin, saxagliptin + metformin (FDC tablet)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Seizures
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions
- Trial name
- NCT01703468
- Testing
- Oxcarbazepine
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy
GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study
The purpose of this study was to assess bioequivalence (BE) of newly developed Glucophage® XR (GXR) reduced mass (RM) tablet (metformin hydrochloride 500 milligrams (mg) test tablet) and marketed Glucophage ® XR tablet (metformin…
- Trial name
- NCT04684420
- Testing
- Glucophage® XR RM Test, Glucophage® XR Reference
- Where
- South Korea
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany