Clinical trials: Fed
Diabetes Mellitus, Type 2
Avandamet Bioequivalence Study Brazil - Fed Administration
The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals.
- Trial name
- NCT01332071
- Testing
- Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg, Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
- Where
- Brazil
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food
The aim of this trial is to establish bioequivalence between EU-, US- and Japan-sourced Otezla® tablet formulations to assure comparability of results from Phase III trials of BI 730357 (new oral agent for treatment of psoriasis…
- Trial name
- NCT04811573
- Testing
- EU-sourced Otezla®, US-sourced Otezla®, Japan-sourced Otezla®
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Critical Illness
Gastric Ultrasound in Tube Fed Intubated Patients
This study will use point of care (POC) gastric ultrasound to confirm that nasojejunal tube (NJ) feeds result in minimal to no gastric content and therefore are low risk for aspiration and should be allowed at the very least to…
- Trial name
- NCT04612348
- Testing
- Ultrasound
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Joseph D. Tobias
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Healthy Participants
Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition
This study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy…
- Trial name
- NCT04916769
- Testing
- Bosutinib capsule
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Prostate Neoplasms, Prostate Cancer
A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone acetate and oral prednisone following short-term administration after standardized low-fat or high-fat meals to patients with metastatic…
- Trial name
- NCT01424930
- Testing
- Abiraterone, Prednisone
- Where
- 2 sites in Canada
- Volunteers
- 25 people
- Sponsor
- Janssen-Ortho Inc., Canada
Healthy
A Multiple-Dose Study of LY3502970 in Healthy Participants
The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states.
- Trial name
- NCT05110794
- Testing
- LY3502970
- Where
- Singapore
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Depressive Disorder
Paxil CR Bioequivalence Study Brazil - Fed Administration
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).
- Trial name
- NCT01339247
- Testing
- Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the…
- Trial name
- NCT01181726
- Testing
- Estradiol/Norethindrone acetate, Activella®
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company)…
- Trial name
- NCT00835081
- Testing
- Cefadroxil 500 mg Capsules, DURICEF® capsules 500 mg
- Where
- 2 sites in United States, Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Gastrointestinal Diseases
Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions
This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration.
- Trial name
- NCT02605395
- Testing
- IDIAZOLE 20mg DR tabs, PARIET 20 mg DR tabs
- Where
- Egypt
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gestational Diabetes, Diagnoses Disease
Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels.
- Conditions
- Gestational Diabetes, Diagnoses Disease, Pregnancy in Diabetic, Glucose, High Blood
- Trial name
- NCT04547023
- Testing
- Fasting before gestational diabetes screen, Per oral intake of food and drink
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Stanford University
Immunogenicity, Healthy Volunteers
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Intas Pharmaceuticals Ltd.
- Trial name
- NCT04015232
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Type 2 Diabetes Mellitus
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
- Trial name
- NCT01068730
- Testing
- metformin (Diabex), metformin (Glucophage™)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Attention-Deficit/Hyperactivity Disorder
Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD
To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules under fed conditions in male or female children 4 to under 6 years of age with ADHD.
- Trial name
- PK003 (NCT02470234)
- Testing
- Methylphenidate HCl ER Capsules, 10 mg, Methylphenidate HCl ER Capsules, 15 mg, Methylphenidate HCl ER Capsules, 20 mg
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Rhodes Pharmaceuticals, L.P.
Opioid Dependence
INDV-2000 First in Human
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction…
- Trial name
- NCT04413552
- Testing
- INDV-2000
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Indivior 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
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relative to Powder in Capsule (PIC) of…
- Trial name
- NCT01154218
- Testing
- crizotinib
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Inflammatory Bowel Diseases
GSK2983559 First Time in Human Study
This study is the first administration of GSK2983559, a selective receptor interacting protein 2 (RIP2) kinase inhibitor, to humans. This will be randomized, double-blinded (sponsor open) and two part study (A and B).
- Trial name
- NCT03358407
- Testing
- GSK2983559
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Topiramate 25 mg Tablets Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed conditions.
- Trial name
- NCT00905567
- Testing
- Topiramate 2 x 25 mg tablet, Topamax® Tablet 2 x 25 mg
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA