Clinical trials: Food Labeling
Healthy Volunteers, Schizophrenia
Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2.
- Trial name
- NCT02748694
- Testing
- TAK-041
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Healthy Subjects
Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214
(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.
- Trial name
- TC-5214 (NCT01458899)
- Testing
- TC-5214
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Adults
A Study to Learn About How Food Affects the Uptake of Study Medicine Prifetrastat Into the Blood in Healthy Adults
The purpose of the study is to assess the effect of food (high-fat, high-calorie meal) on the total and peak drug exposure of the planned to be marketed tablet formulation of prifetrastat.
- Trial name
- NCT07731100
- Testing
- Prifetrastat
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Solid Tumors
An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820 to Determine the Maximum Tolerated Dose Following Twice Daily Oral Administration in Subjects With Unresectable Solid Tumors
This study consists of two Parts. Part A (Food Effect Study) and Part B (Determination of Maximum Tolerated Dose [MTD] for twice daily [BID] Dosing).Part A will be initiated first, and Part B will be initiated after the PK…
- Trial name
- NCT01773421
- Testing
- E7820
- Where
- 6 sites in Netherlands, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Eisai Inc.
Healthy Subject
A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers
This was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet.
- Trial name
- NCT05358756
- Testing
- SACT-1, EDURANT 25Mg Tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Aptorum International Limited
Child Malnutrition
Post Discharge Trial to Enhance Immunity in Severely Malnourished Children
The goal of this study is to evaluate the efficacy of microbiota-directed food in comparison to zinc with micronutrient powder and Khichuri on changes in circulating immune cells (monocytes, T cells, B cells, and NK cells) in…
- Trial name
- NCT06530485
- Testing
- Microbiota-directed food, Khichuri
- Where
- Bangladesh
- Volunteers
- 154 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Healthy Volunteers
Investigate Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers
The purpose of this study is to assess bioequivalence of the granule formulation of alpelisib as compared to the film-coated tablet formulation in healthy volunteers in the fed state.
- Trial name
- NCT05195892
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United Kingdom
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Gonorrhea
Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin
This is a phase I, parallel, open-label, randomized, cross-over, single-center study with zoliflodacin administered as granules for oral suspension with or without food.
- Trial name
- NCT03718806
- Testing
- Zoliflodacin, high calorie, high fat breakfast
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Healthy
A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food
The main objective of this trial is to investigate the potential effect of food on the pharmacokinetics of BI 425809 following administration of the intended Commercial Formulation (iCF) with food (Test treatment, T) and without…
- Trial name
- NCT05347004
- Testing
- BI 425809
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation
The main purpose of the study was to evaluate the effect of food on the single-dose pharmacokinetics of an oral solution of levofloxacin.
- Trial name
- NCT00601432
- Testing
- levofloxacin oral solution
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood.
The primary objective of the single-rising dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730460 in healthy subjects following oral administration of single rising doses.
- Trial name
- NCT03483077
- Testing
- BI 730460
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Cow Milk Allergy
Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula
This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein…
- Trial name
- STORY (NCT05618704)
- Testing
- Hydrolyzed protein infant formula
- Where
- Poland
- Volunteers
- 69 people
- Sponsor
- Nutricia Research
To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
This is an open-label study to understand the safety and tolerability of AXA4010, a novel composition of amino acids in adult and adolescent subjects with sickle cell disease over 12 weeks.
- Conditions
- To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell, Sickle Cell Anemia, Sickle Cell Disorders
- Trial name
- NCT04134299
- Testing
- AXA4010
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc
Myelofibrosis
To Evaluate the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects
TQ05105 is a class 1 new drug with a new chemical structure developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. It is a Janus Kinase 2 （JAK2）inhibitor and can be used to treat JAK2 target-related diseases.
- Trial name
- NCT05982106
- Testing
- TQ05105 Tablets
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy Participants
A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years
The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the effect of food on these formulations in healthy participants.
- Trial name
- NCT07455825
- Testing
- AZD5004
- Where
- 2 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioavailability
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
This is a single center, Phase 1, randomized, open-label, single-dose, 4 treatment, 4-period, 4-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin from the Test and Reference products, and to…
- Trial name
- NCT06481709
- Testing
- RLF-OD032, Kuvan
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Healthy
Bioavailability Study Comparing 2 Vamifeport Oral Formulations in Fasted Versus Fed State in Healthy Subjects
Two different vamifeport oral formulations will be administered in fed and fasted state to assess the vamifeport food-drug interaction and to assess the relative bioavailability (the proportion of drug entering the circulation)…
- Trial name
- NCT05077436
- Testing
- Vamifeport Formulation 1, Vamifeport Formulation 2
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Vifor (International) Inc.
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
A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food
The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R).
- Trial name
- NCT04789291
- Testing
- BI 1595043
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Irritable Bowel Syndrome Characterized by Constipation
Food Supplement Physiomanna® Baby in Pediatric Patients
The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation The secondary objective of the trial is to evaluate the adherence…
- Trial name
- NCT02732743
- Testing
- Physiomanna® Baby
- Where
- Romania
- Volunteers
- 45 people
- Sponsor
- Iuppa Industriale Srl