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.
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
Solid Tumors, Hematological Malignancies
A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors
This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect of food on the bioavailability of AXL1717 including patients with advanced malignant tumors
- Trial name
- NCT01725555
- Testing
- Fasted treatment: AXL1717, Fed treatment: AXL1717
- Where
- Sweden
- Volunteers
- 13 people
- Sponsor
- Axelar AB
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
Idiopathic Pulmonary Fibrosis
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects
The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and Female Subjects
- Trial name
- NCT04512170
- Testing
- HEC585
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy
A Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets
Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.
- Trial name
- NCT00879346
- Testing
- AZD8931
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Prostatic Hyperplasia
A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia
This study is an open-label, randomized, single dose, multi-stage, cross-over study in healthy male subjects of North East Asian ancestry.
- Trial name
- NCT01495026
- Testing
- Dutasteride (0.5mg, fasted state), Dutasteride (0.5mg, fed state), Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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 Test How 3 Different Formulations of BI 764198 Are Taken up in the Body and How This is Influenced by Food
This trial aims to investigate the relative bioavailability of three different oral formulations of BI 764198 and how this is influenced by food.
- Trial name
- NCT06955754
- Testing
- BI 764198, formulation 1, BI 764198, formulation 2, BI 764198, formulation 3
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Lung Infection, Microbial Colonization
FMT for Lung and Associated-organ Rescue Efficacy in MDRO-infected Ventilated Patients
Multidrug-resistant organism (MDRO)-infection represents a substantial global health burden. In the intensive care unit (ICU), the concurrent administration of antibiotics, opioids, proton pump inhibitors (PPIs)…
- Conditions
- Lung Infection, Microbial Colonization, Food Intolerance Syndromes
- Trial name
- FLARE-MV (NCT06970262)
- Testing
- Fecal suspension
- Where
- China
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Type 2 Diabetes
Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)
- Trial name
- NCT01747083
- Testing
- FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Volunteers
Study to Evaluate the Effect of Food on the Pharmacokinetics of a BGB-3111 in Healthy Subjects
Phase 1 study in healthy subjects to determine the effect of food on the pharmacokinetics of BGB-3111.
- Trial name
- NCT04163523
- Testing
- Zanubrutinib
- Where
- 5 sites in Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- BeiGene
Healthy
Food Effect Study For New Formulation
The main objective of this study is to estimate the effect of food on sildenafil pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of sildenafil citrate.
- Trial name
- NCT01656798
- Testing
- sildenafil citrate
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.