Clinical trials: Food Labeling
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
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
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.
Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects
The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate…
- Trial name
- NCT01374139
- Testing
- Bosutinib
- Where
- Singapore
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Pfizer
Safety and Pharmacokinetics in Healthy Volunteer Subjects
A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects
Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male subjects; and to evaluate the…
- Trial name
- AME/FE (NCT01611467)
- Testing
- CC-223
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Celgene
Healthy
Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone
The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule…
- Trial name
- NCT01456507
- Testing
- ALO-02 (Oxycodone Naltrexone)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Bioavailability and Pharmacokinetics of BI 10773 Tablet in Healthy Male Volunteers
Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a single dose BI 10773 tablet in healthy subjects
- Trial name
- NCT02172209
- Testing
- BI 10773
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV-1-infection, Hepatic Impairment
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs
This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the…
- Trial name
- NCT03706898
- Testing
- Elpida®, Dolutegravir, Sofosbuvir
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Viriom
Healthy Volunteers
Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric and Adult Branaplam Formulation in Healthy Adults and the Effect of Food on the Latter.
This is a Phase 1 study designed to assess the relative bioavailability (BA), safety and tolerability and PK of the pediatric and adult formulations of branaplam.
- Trial name
- NCT05330286
- Testing
- LMI070
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals