Clinical trials: Fed
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
Allergies
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fed conditions.
- Trial name
- NCT00881634
- Testing
- Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA), Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sandoz
Nausea, Vomiting
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions
The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fed…
- Trial name
- NCT00618111
- Testing
- Granisetron
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.
- Trial name
- NCT00648219
- Testing
- Olmesartan Medoxomil Tablets 40 mg, Benicar® Tablets 40 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fed conditions.
- Trial name
- NCT01131936
- Testing
- Amlodipine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivaelnce Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fed Conditions
To compare the single-dose oral bioavailability of clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin 250 mg/5 mL granules for oral suspension in healthy, adult, human, male subjects under…
- Trial name
- NCT00775372
- Testing
- Clarithromycin 250mg/5mL
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fed Conditions
Objective: Primary objective of the present study was to compare the single dose bioequivalence of Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the study were separated by a washout period of 7 days.
- Trial name
- NCT01634399
- Testing
- Torrent's Quetiapine Fumarate Tablets
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy Volunteers
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fed Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080534
- Testing
- Tacrolimus 5 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Healthy
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers
To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs. fed (food effect for the tablet).
- Trial name
- NCT02259972
- Testing
- BI 113823 solution, BI 113823 tablet, High fat, high calorie breakfast
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men
To assess the effect of food on the pharmacokinetics of an oral tablet formulation of BI 1291583, by investigating the relative bioavailability following single dose administration under fed and fasted conditions.
- Trial name
- NCT03837964
- Testing
- BI 1291583
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Stool Composition
Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.
- Trial name
- NCT01861600
- Testing
- S-26 Gold, S-26 Gold EF1, S-26 Gold EF2
- Where
- Philippines
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy
Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fed Conditions
The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other.
- Trial name
- NCT01665209
- Testing
- Morphine Sulfate
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Inc.
Healthy
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
This is an single dose,two-way, crossover, oral bioequivalence study.
- Trial name
- NCT01513681
- Testing
- Lamotrigine, Lamictal®
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Growth and Tolerance
Growth of Infants Fed Hydrolysate Formulas
Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.
- Trial name
- NCT02006992
- Testing
- RTF Infant Formula, Powder Infant Formula
- Where
- 8 sites in United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Colon Cancer, Breast Cancer
A Bioequivalence Study of Capecitabine Tablets 500 mg in Adult Cancer Patients Under Fed Condition
Purpose: To demonstrate the bioequivalence between Capecitabine Tablets 500 mg of Qilu Pharmaceutical Co., Ltd, China in comparison with XELODA® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA, Inc.
- Trial name
- Capecitabine (NCT03435666)
- Testing
- Capecitabine, XELODA
- Volunteers
- 45 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Infant, Newborn
Tolerance of Healthy Term Infants Fed Infant Formulas
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
- Trial name
- NCT00705562
- Testing
- milk protein formulas, varying carbohydrate/protein sources
- Where
- 15 sites in United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Healthy Volunteers
A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions
The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fed conditions to healthy adult volunteers.
- Trial name
- NCT05729386
- Testing
- GC2129A(Period 1), Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1), GC2129A(Period 2)
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura
Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
This will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, Lots…
- Conditions
- Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura, Chronic Thrombocytopenia
- Trial name
- NCT01327872
- Testing
- E5501 40 mg 2 x 20-mg tablets, orally, fasted, E5501 40 mg 2 x 20-mg tablets, orally, with food, E5501 40mg 2 x 20-mg tablets, orally, fasted
- Where
- Netherlands
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy
To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet
The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg caffeine against 400 mg ibuprofen alone under fed conditions
- Trial name
- NCT02629354
- Testing
- Ibuprofen, Caffeine
- Where
- South Africa
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers
The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to…
- Trial name
- NCT00973232
- Testing
- DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), DDS-06C (650 mg acetaminophen and 75 mg tramadol), Zaldiar®
- Where
- United Kingdom
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Labopharm Inc.