Clinical trials: Food Labeling
Healthy
Food Effect Study of CTP-543 in Healthy Volunteers
Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.
- Trial name
- NCT03880136
- Testing
- CTP-543
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Food Allergy
Expanded Access of Dupilumab in Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy Previously Treated With Linvoseltamab
This is an expanded access program of dupilumab. The objective of the program is to provide continued dupilumab to adult participants with severe IgE-mediated food allergy who were previously treated with a short course of…
- Trial name
- NCT06631677
- Testing
- Dupilumab
- Sponsor
- Regeneron Pharmaceuticals
Kidney Transplantation
An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients
The purpose of this study is to evaluate the effect of food on the oral bioavailability of tacrolimus modified release (MR4) capsules together with a standard continental breakfast.
- Trial name
- NCT00865137
- Testing
- Tacrolimus, modified release
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Astellas Pharma Inc
Type 2 Diabetes Mellitus
ECC5004 RBA FE Study in Healthy Participants
This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet…
- Trial name
- NCT06268145
- Testing
- ECC5004
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Eccogene
Healthy
To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults
The purpose of this study is to learn about the study medicine CTB-AVP for the treatment of severe urinary tract infections that require hospitalization.
- Trial name
- NCT06593054
- Testing
- Ceftibuten, Avibactam prodrug, CTB-AVP in Tablet
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants
The purpose of this study is to assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of…
- Trial name
- NCT05963932
- Testing
- BMS-986419 DR Capsule, BMS-986419 IR Tablet
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Volunteers
Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants
The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.
- Trial name
- NCT05134350
- Testing
- LOXO-305, Omeprazole
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Loxo Oncology, Inc.
Idiopathic Pulmonary Fibrosis
To Evaluate Food Effect on the PK and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers
The pharmacokinetics (PK) and safety of single oral dose of DWN12088 in healthy adults will be compared and assessed on an empty stomach, after high-fat meal, or 2 hours after high-fat meal.
- Trial name
- NCT04767815
- Testing
- Diet A group, Diet B group, Diet C group
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy Volunteers
A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to…
- Trial name
- NCT05152485
- Testing
- BIIB104 Reference Formulation, BIIB104 Test Formulation
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biogen
Huntington Disease, Tardive Dyskinesia
Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets
This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164…
- Trial name
- NCT06474650
- Testing
- LPM3770164 sustained release tablet
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy Participants
A Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects
This study is a single-dose, randomized, open-label, three-sequence, three-period crossover clinical trial to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of ammoxetine hydrochloride enteric-coated…
- Trial name
- NCT07508462
- Testing
- Ammoxetine hydrochloride enteric-coated tablets
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Food Allergy in Infants, Nut Allergy
The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Peanut Allergy
Early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. It is not clear whether this is also true of tree nut allergy.
- Trial name
- TreEat (NCT04801823)
- Testing
- Home introduction, Multi Nut oral food challenge
- Where
- Australia
- Volunteers
- 212 people
- Sponsor
- Murdoch Childrens Research Institute
HIV Infections
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate…
- Trial name
- NCT04128293
- Testing
- GSK3640254 Tablet, GSK3640254 Capsule
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Food Labelling
Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus Cafeterias
This study evaluates the impact of the introduction of a front-of-pack nutrition label on fods and beverages sold in a campus cafeteria in France on the nutritional quality of purchases.
- Trial name
- 5-C CROUS (NCT02663401)
- Testing
- Front-of-pack labelling 5-CNL
- Where
- France
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Paris 13
Healthy Participants, Epilepsy
A Study to Test the Blood Concentration of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil
The purpose of the study in Part 1, is to evaluate (under fasted conditions) the plasma pharmacokinetics (PK) of padsevonil (PSL) using 4 PSL product variants against a PSL reference tablet and in Part 2, to evaluate the PK of…
- Trial name
- NCT04283136
- Testing
- Padsevonil type 1 Tablet 200 mg, Padsevonil type 2 Tablet, Padsevonil type 3 Tablet
- Volunteers
- healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Healthy Adult Volunteers
A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants
The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of BMS-986196 tablet formulation at two dose…
- Trial name
- NCT06034899
- Testing
- BMS-986196
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Transfusional Hemosiderosis
Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food
This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20 centers. All patients who met the study criteria and were taking, beginning or resuming treatment with Deferasirox were allowed.
- Trial name
- NCT00845871
- Testing
- deferasirox:
- Where
- 23 sites in United States
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Diet, Healthy
Front-of-package Label Effects in Latine and Limited English Proficiency Populations
The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults.
- Trial name
- NCT06293963
- Testing
- Guideline Daily Amounts label, Interpretive text-only label, Interpretive magnifying glass icon label
- Where
- United States
- Volunteers
- 3,306 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Healthy
Bioavailability of Omega-3 Food Supplements in Healthy Subjects
The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted conditions in healthy adult subjects. Each subject will participate in 5 treatment periods.
- Trial name
- NCT02376621
- Testing
- PronovaPure 150:500 triglycerides, Pronovum PRF-048, Pronovum PRF-037
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pronova BioPharma
Healthy Volunteers
A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation
The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when…
- Trial name
- NCT03101293
- Testing
- TAK-831
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences