Clinical trials: Food Labeling
Healthy Volunteer
A Pharmacokinetic Study in Healthy Participants to Assess the Pharmacokinetics and Safety of a Supratherapeutic Dose of PCI-32765 (Ibrutinib) Capsule and Solution Formulations Administered With Food
The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) in healthy adult volunteers.
- Trial name
- NCT01969266
- Testing
- Treatment A: PCI-32765, Treatment B: PCI-32765
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
- Trial name
- NCT02097329
- Testing
- palbociclib commercial free base, famotidine, rabeprazole
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Pfizer
NASH - Nonalcoholic Steatohepatitis
An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD
The primary objective of the study is to compare the changes in ALT to baseline among patients with non-alcoholic fatty liver disease (NAFLD) following the 3-month treatment of 3 different dosing regimens of SNP-612.
- Trial name
- NCT03868566
- Testing
- SNP-612 dose1, SNP-612 dose2
- Where
- Taiwan
- Volunteers
- 90 people
- Sponsor
- Sinew Pharma Inc.
Healthy
Relative Bioavailability Study and Food Effect Study of TT-00420 (Tinengotinib) Capsule and Tablet Formulations in Healthy Volunteers
This study is an open-label, 3-way crossover randomized study in adult healthy volunteers to evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to evaluate food effect on the pharmacokinetics of…
- Trial name
- NCT04705922
- Testing
- TT-00420 Capsule, TT-00420 Tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Clinical Pharmacology
Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects
This is a randomized, open-label, crossover study to determine the effect of food when a combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as SYR-322-MET tablet) is orally administered under…
- Trial name
- NCT02276274
- Testing
- SYR-322-MET
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers in Fed and Fasted State
Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption and the overall bioavailability of a single dose of CTx-1301 25 mg trimodal tablets in healthy adult volunteers.
- Trial name
- Fed-Fast (NCT04449250)
- Testing
- Dexmethylphenidate
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Cingulate Therapeutics
Healthy Volunteers
Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
Primary Objective: To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects.
- Trial name
- NCT04748926
- Testing
- rilzabrutinib SAR444671
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Principia Biopharma, a Sanofi Company
Healthy
Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State
The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women
- Trial name
- NCT03670082
- Testing
- Lu AF35700, Lu AF35700 iv
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435
The purpose of this study is to investigate the effect of food on the pharmacokinetics (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male participants.
- Trial name
- NCT01799603
- Testing
- TMC435
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Acromegaly
A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25)
The goal of this clinical trial] is to to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25 in healthy volunteers. The main questions it aims to answer are： 1.
- Trial name
- NCT07663318
- Testing
- T25-Fast, Mycapssa, T25-Fed
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Triastek (Shanghai) Limited
Cardiovascular Abnormalities
Evaluation of the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects
This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001, R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec).
- Trial name
- NCT02616913
- Testing
- R,R-monatin, Moxifloxacin
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Cargill
Healthy
A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood
This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further…
- Trial name
- NCT06255340
- Testing
- BI 3031185
- Where
- Germany
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Antitumor Drug, Pharmacokinetics
SPH3348 Tablets in a Single-center, Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design Food Effect Study in Healthy Chinese Subjects
The goal of this clinical trial is to evaluate the pharmacokinetic (PK) characteristics of single oral doses of SPH3348 tablets in healthy subjects under fasting and fed conditions, as well as the impact of food on PK.
- Trial name
- NCT06652997
- Testing
- SPH3348
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- West China Second University Hospital
Healthy Volunteer
A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on…
- Trial name
- NCT01287091
- Testing
- GDC-0980, rabeprazole
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy
A Food Effect Study in Healthy Volunteers With Belzutifan (PT2977, MK-6482) Tablets
This Phase 1, single-dose study will be conducted in adult male and female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria.
- Trial name
- NCT03445169
- Testing
- Belzutifan
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Healthy
PPI And Food Effect Study For PF-06463922 In Healthy Volunteers
The current study will be conducted in healthy adult subjects to evaluate the effect of proton pump inhibitor and food on pharmacokinetics of PF-06463922, to evaluate the bioavailability of the oral solution relative to the…
- Trial name
- NCT02569554
- Testing
- PF-06463922, rabeprazole
- Where
- Belgium
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.
- Trial name
- NCT04393597
- Testing
- DWJ1458 (fasted), DWJ1458 (fed)
- Where
- South Korea
- Volunteers
- healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy Volunteer
Neuroeconomic Approach of Food Nutritionnal Assesment
This fMRI study evaluated the cognitive mechanisms and the cerebral substrate of decision making when evaluating the healthiness of food products with nutritional information displayed either with a Traffic Light system, a…
- Trial name
- NeuroFood (NCT02841410)
- Testing
- Magnetic Resonance Imaging
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University Hospital, Grenoble
Healthy Volunteers
A Single Oral Dose Study to Evaluate Four Different Formulations of AZD9977 and the Effect of Food in Healthy Male Subjects
This study will evaluate pharmacokinetics (PK) of four different formulations with different release profiles of AZD9977 (PART A) in the fasted state, and one of the formulation will be selected for further development (Part B).
- Trial name
- NCT03450759
- Testing
- AZD9977 Oral suspension (reference), AZD9977 capsule, AZD9977 ER capsule (fastvrate)
- Where
- United Kingdom
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Filariasis
Relative Bioavailability Study of Emodepside IR-tablets and Solution
This study evaluates 2 new immediate release (IR)-tablet formulations of emodepside and they will be compared to the oral liquid service formulation (LSF) used in the FIH Single Ascending Dose study (DNDi-EMO-001 study) (CT.gov…
- Trial name
- NCT03383523
- Testing
- Emodepside (BAY 44-4400)
- Where
- United Kingdom
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases