Clinical trials: Food Labeling
Healthy Volunteer
A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.
This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group 2) on the single oral dose pharmacokinetics of alectinib in healthy volunteers.
- Trial name
- NCT02023125
- Testing
- Alectinib, Esomeprazole, High Fat and Calorie Meal
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
Evaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential
This study will be an open-label, randomized, three-period, six-sequence crossover study of GDC-9545 administered to healthy females of non-childbearing potential to determine the relative bioavailability of the Phase 3 capsule…
- Trial name
- NCT04274075
- Testing
- GDC-9545 Tablet, Fasted: Treatment A, GDC-9545 Capsule, Fasted: Treatment B, GDC-9545 Capsule, Fed: Treatment C
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy
A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects
The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.
- Trial name
- NCT02372344
- Testing
- AZD0585
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pharmacokinetics
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
Grapefruit juice is an inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the enzyme systems responsible for the metabolism of colchicine.
- Trial name
- NCT00984009
- Testing
- Colchicine, Grapefruit Juice
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy Volunteers, Adult
A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants
The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults.
- Conditions
- Healthy Volunteers, Adult, Pharmacokinetics
- Trial name
- NCT05852340
- Testing
- Ritlecitinib
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food
The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the pharmacokinetics of the new formulation following oral administration.
- Trial name
- NCT06624072
- Testing
- Nerandomilast 18 mg - adult formulation, Nerandomilast 1 mg - paediatric formulation
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Peanut Allergy
Salvage Peanut Oral Immunotherapy Study
The purpose of this trial is to study the safety of rescue peanut oral immunotherapy followed by the introduction of dietary peanut for patients with peanut allergy who have lost desensitization during a peanut immunotherapy…
- Trial name
- SOIT (NCT03251508)
- Testing
- Peanut OIT
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of North Carolina, Chapel Hill
Healthy
A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT03794323
- Testing
- BI 764122
- Where
- Belgium
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Acne
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.
- Trial name
- NCT02457520
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Sun Pharmaceutical Industries Limited
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
Sarcoma
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms…
- Trial name
- NCT01896505
- Testing
- KCP-330
- Where
- 2 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Karyopharm Therapeutics Inc
Healthy Volunteers
A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet
The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men…
- Trial name
- NCT03456960
- Testing
- TAK-438ASA, TAK-438, Aspirin
- Where
- Japan
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Participants
A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants
The purpose of the study is to estimate the relative bioavailability of a new minzasolmin tablet formulation versus reference 'granules in capsule' formulation in healthy participants and to evaluate the effect of food with the…
- Trial name
- NCT06533475
- Testing
- Minzasolmin tablet formulation under fasting condition, Minzasolmin Granules in capsule under fasting condition, Minzasolmin tablet formulation under fed condition
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Healthy Volunteers
A Study of TAK-227 in Healthy Adults
The main aim of this study is to test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to…
- Trial name
- NCT05818956
- Testing
- TAK-227
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Peanut Allergy
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17…
- Trial name
- NCT03703791
- Testing
- AR101
- Where
- 11 sites in Spain
- Volunteers
- 1 people
- Sponsor
- Aimmune Therapeutics, Inc.
Japanese Premenopausal Healthy Adult Women
A Food Effect Study of TAK-385 Final Formulation
The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.
- Trial name
- NCT02792062
- Testing
- TAK-385 40 mg
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food
The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1810631 intended commercial formulation (iCF) under fed (Test treatment, T) and fasted (Reference treatment, R) conditions.
- Trial name
- NCT06075277
- Testing
- zongertinib
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood
This trial investigates whether food influences the amount of BI 3731579 in the blood.
- Trial name
- NCT06861829
- Testing
- BI 3731579
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Taste Assessment Study of SHP429 in Healthy Adult Subjects
The purpose of this study is to compare the palatability of SHP429 capsule contents delivered via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into a cup and administered with water).
- Trial name
- NCT02125292
- Testing
- Mesalamine
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Shire
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