Clinical trials: Food Labeling
Healthy
A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food
To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI…
- Trial name
- NCT05155306
- Testing
- BI 1358894, intended Commercial Formulation (iCF) (T), BI 1358894, Trial Formulation 2 (TFII) (R)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Advanced Non Small Cell Lung Cancer, Advanced (Inoperable) Non Small Cell Lung Cancer
Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer
This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor…
- Trial name
- NCT02163733
- Testing
- AZD9291 tablets, Pharmacokinetic sampling - AZD9291, Dietary Fasted
- Where
- 13 sites in France, South Korea and 2 more
- Volunteers
- 38 people
- Sponsor
- AstraZeneca
Healthy
Drug-Food Interaction Study of Seville Orange Juice and Colchicine
Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one of the enzymes responsible for the metabolism of colchicine.
- Trial name
- NCT00960193
- Testing
- Colchicine, Seville Orange Juice
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Malaria
Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.
This trial aims to characterise the pharmacokinetic (PK) profile and estimate drug exposure of a single oral dose of piperaquine (PQP) in a dispersible granule formulation compared to the PQP hard tablet formulation in the fasted…
- Trial name
- PedPQP(BA/FE) (NCT05930782)
- Testing
- Piperaquine Tetraphosphate uncoated tablets, Piperaquine Tetraphosphate dispersible granules
- Where
- Tanzania
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Healthy
Bioequivalence of TF3 and TF2 and Effect of Food on the PK of Tepotinib
The main purpose of the study was to demonstrate bioequivalence between the new tablet formulation (TF3, test treatment) and the tablet formulation used in clinical studies (TF2, reference treatment) and to investigate effect of…
- Trial name
- NCT03629223
- Testing
- Tepotinib TF2, Tepotinib TF3
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
HIV Infections
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
This is an open-label, 2 part, single-dose and crossover study conducted to assess the relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the effect of food on the GSK3640254 tablet in healthy…
- Trial name
- NCT04263142
- Testing
- GSK3640254 Tablet, GSK3640254 Capsule
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
Study in Healthy Adults Evaluating PF-07202954
The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).
- Trial name
- NCT04857437
- Testing
- PF-07202954 Repeat Dose, PF-07202954 Single Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir
The primary objective of this trial is to investigate the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.
- Trial name
- NCT01694706
- Testing
- faldaprevir, omeprazole
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Peanut Hypersensitivity
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the…
- Trial name
- NCT00382148
- Testing
- omalizumab
- Volunteers
- 11 people
- Sponsor
- Genentech, Inc.
Healthy Volunteers
A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation
The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK following single oral administration of TAK-536 pediatric formulation in Japanese healthy adult male participants.
- Trial name
- NCT03434977
- Testing
- TAK-536
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
HIV Infections
A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants
This is a two part study to compare the relative bioavailability (BA) of 2 fixed dose combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single agents (Part 1) and to assess the effect of food…
- Trial name
- NCT04857892
- Testing
- GSK3640254, DTG, GSK3640254/DTG
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
Bioavailability of Different Applications of Dabigatran in Healthy Volunteers
To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution, both with 150 mg of dabigatran etexilate as…
- Trial name
- NCT02171611
- Testing
- Dabigatran etexilate pellets, Dabigatran etexilate powder, Dabigatran etexilate capsule
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Erectile Dysfunction
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
- Trial name
- NCT01254396
- Testing
- Sildenafil
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Volunteers
A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body.
- Trial name
- NCT06268301
- Testing
- Budesonide
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
A Study in Healthy Men to Test Whether Food Affects the Amount of BI 894416 in the Blood
Investigate the relative bioavailability of BI 894416 as tablet formulation following a high-fat, high calorie breakfast (Test, T) compared with administration in the fasting state (Reference, R)
- Trial name
- NCT03871595
- Testing
- BI 894416
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Parkinson's Disease
Relative Bioavailability and Food Effect Study of CVN424
This is a Randomized, Open-Label, Single Oral Dose, Three-Way Cross-Over Trial to Evaluate the Relative Bioavailability of CVN424 Suspension and Tablet Formulations in Healthy Volunteers Under Fasted and Fed Conditions.
- Trial name
- NCT05635461
- Testing
- CVN424
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cerevance Beta, Inc.
Smoking Cessation
A Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine
This will be an open-label, randomised, 2-period, single-dose crossover study to determine the comparative bioavailability of cytisine following single-dose administration in healthy male and female subjects under fed and fasted…
- Trial name
- NCT03268343
- Testing
- Cytisine
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Achieve Life Sciences
Food Effect in Healthy Participants
Evaluation of the Potential Impact of a High-fat Meal on the Pharmacokinetics of CRS3123 in Healthy Adult Participants
This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants.
- Trial name
- NCT06988423
- Testing
- CRS3123 200 mg capsule
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Crestone, Inc
Schizophrenia
Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.
- Trial name
- NCT06036108
- Testing
- OPC-34712FUM/ Brexpiprazole fumarate
- Where
- Japan
- Volunteers
- 59 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy Volunteers
Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension
The purpose of this study is to assess how much of apremilast is found in the blood unchanged when administered as an oral suspension compared to when it is administered as a tablet formulation.
- Trial name
- NCT02641353
- Testing
- Apremilast Tablet, Apremilast Oral Suspension
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Amgen