Clinical trials: Fed
Healthy
Fed Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose…
- Trial name
- NCT01183676
- Testing
- DEPAKOTE® Tablets, 500 MG, DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition
The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fed…
- Trial name
- NCT01053689
- Testing
- Glimepiride tablets 1 mg
- Where
- Canada
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Diabetes Mellitus
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5…
- Trial name
- NCT01192152
- Testing
- saxagliptin, Glucophage XR, saxagliptin + metformin XR (FDC tablet)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Infant Gut Microbiome
The EFFECT Study: Probiotic and HMO Supplementation in Infants
Lacto-N-tetraose (LNT) is a human milk oligosaccharide (HMO) present in human colostrum and milk. HMOs are largely undigestable and have no direct nutritive benefit to the infant, but act as a prebiotic substrate for beneficial…
- Trial name
- EFFECT (NCT03994315)
- Testing
- B. infantis EVC001, Lacto-N-tetraose (LNT)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Evolve BioSystems, Inc.
Infant Formula Intolerance, Well-being
Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants
Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual nutrients as compared to breast-milk in term…
- Trial name
- NCT03178474
- Testing
- JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®, TOFER Infant formula,TOFER®, Breast milk
- Where
- 3 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
Trypanosomiasis, African
Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of the tablet formulation used in the clinical trials and the final marketed tablet formulation under fed condition.
- Trial name
- NCT02571062
- Testing
- Fexinidazole
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Healthy Subjects
Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers
This study is designed to first evaluate the effect of food on E7050's pharmacokinetic parameters following the administration of single 100 mg oral doses of E7050 tablet to each normal healthy participant in the study (Part A)…
- Trial name
- NCT02533102
- Testing
- E7050
- Where
- Netherlands
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eisai Limited
Cardiovascular Disease, Pulmonary Arterial Hypertension
Effect of BIA 5 1058 on Cardiac Repolarization
The purpose is to evaluate the effect of single therapeutic (400 mg) and supratherapeutic (1200 mg) doses of BIA 5-1058 on the time-matched change from baseline in placebo-adjusted interval corrected (QT) for heart rate (HR)
- Conditions
- Cardiovascular Disease, Pulmonary Arterial Hypertension, Heart Failure
- Trial name
- NCT03489005
- Testing
- BIA 5-1058, Moxifloxacin 400 mg
- Where
- United Kingdom
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy
Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions
The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc.
- Trial name
- NCT00829790
- Testing
- Doxycycline Monohydrate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Subjects
A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers in Fed Condition
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6013 and each component in healthy adult volunteers in fed condition.
- Trial name
- NCT05874180
- Testing
- DW6013
- Where
- South Korea
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Dong Wha Pharmaceutical Co. Ltd.
Healthy
Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets 500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy subjects.
- Trial name
- NCT01132196
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study of Canagliflozin and Metformin Immediate Release (150 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
- NCT01508182
- 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
Healthy
First-in-Human Single Ascending Dose of GLPG0492
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects.
- Trial name
- NCT01130818
- Testing
- GLPG0492
- Where
- Belgium
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to…
- Trial name
- NCT00897390
- Testing
- Saxagliptin, Metformin IR (glucophage), Saxagliptin + Metformin IR (FDC)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fed Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of Risperidone formulations after administration of single doses to normal, healthy subjects under fed conditions.
- Trial name
- NCT01222923
- Testing
- Risperidone
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Paroxetine Hydrochloride 40 mg Tablets Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 40 mg film-coated tablets (test) and Paxil® (reference) administered as 1 x 40 mg film-coated tablet under fed conditions.
- Trial name
- NCT00841659
- Testing
- Paroxetine HCl, Paxil®
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Cardiovascular Diseases
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
This study is a randomized, open-label, fed, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions.
- Trial name
- NCT04083846
- Testing
- Reference drug, Test drug 1, Test drug 2
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy Volunteers
Food Effect Study of AG-221 in Healthy Male Subjects
AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer treatment.
- Trial name
- NCT02218346
- Testing
- AG221
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy Volunteer
The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions
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
- NCT06244407
- Testing
- Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Bio service
Immune System Disorder, Healthy Volunteers
A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
The purpose of this study is to evaluate safety and pharmacokinetics (PK) effect of belumosudil on the uridine diphosphate glucuronosyltransferase (UGT)1A1 (Part 1), P glycoprotein (P-gp) (Part 2) and breast cancer resistance…
- Trial name
- NCT05806567
- Testing
- Belumosudil, UGT1A1 victim drug, P-gp victim drug
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
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