Clinical trials: Food Labeling
Healthy Volunteers
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
This is a single center, Phase 1, randomized, open-label, single-dose, 3 treatment, 3-period, 6-sequence, crossover study designed to compare the PK of SMP-100 dissolved in water for oral administration with SMP-100 tablets under…
- Trial name
- NCT05029518
- Testing
- SMP-100
- Where
- Australia
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
Healthy Participants
A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD8965 in Healthy Participants (Including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy participants (including Japanese and Chinese participants), and to assess…
- Trial name
- NCT06502379
- Testing
- AZD8965
- Where
- United States
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Healthy
A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants
The purpose of this study is to assess the food effect on the single-dose pharmacokinetic (PK) of the JNJ-64417184 oral solution, administered as 2 different formulations, in healthy adult participants.
- Trial name
- NCT04258189
- Testing
- JNJ-64417184
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Sleep Initiation and Maintenance Disorders
Bioequivalence and Food Effect Study in Healthy Volunteers
The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.
- Trial name
- NCT00495274
- Testing
- Formulation A, Formulation B, Formulation C
- Where
- Italy
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Food Effect Study of ZN-d5 in Healthy Female Volunteers
This is a single-center, sequential, open-label, food effect study to determine the comparative bioavailability of ZN-d5 under fasting and fed conditions, following single-dose oral administration of ZN-d5.
- Trial name
- NCT04854174
- Testing
- ZN-d5
- Where
- New Zealand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Healthy
Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects
This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations.
- Trial name
- NCT07240116
- Testing
- Miricorilant Treatment A, Miricorilant Treatment B, Miricorilant Treatment C
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Corcept Therapeutics
Melanoma, Malignant Melanoma
Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach
- Trial name
- NCT00710515
- Testing
- AZD6244
- Where
- 6 sites in Netherlands, United Kingdom
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis, Healthy Volunteers
A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food.
- Trial name
- NCT00838058
- Testing
- CE-224,535, CE 224,535
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
AZD4635 Relative Bioavailability Study
To investigate the pharmacokinetics and relative bioavailability of AZD4635 solid oral formulation and compare with the nano-suspension reference formulation with the option to assess food effect, pH effect and absolute…
- Trial name
- Rel Bio (NCT03710434)
- Testing
- AZD4635 50 mg nano-suspension (reference), AZD4635 solid oral formulation - fasted, AZD4635 solid oral formulation - fed
- Where
- United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants
This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773.
- Trial name
- NCT03847987
- Testing
- RO7017773 Phase I Capsule, RO7017773 Phase II Tablet Unflavored, RO7017773 Phase II Tablet Sweetened/Flavored
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
Evaluation Of The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And Food Effect In Healthy Subjects
The purpose of this study is to estimate the bioavailability of PF-04457845 tablets relative to solution and evaluate the effect of food (fasted vs.
- Trial name
- NCT00918164
- Testing
- PF-04457845
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food
The main objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2.
- Trial name
- NCT06415045
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation
This study is intended to establish the bioequivalence (BE) of single 100 mg doses of glasdegib administered under fasted conditions to healthy volunteers as the ICH formulation compared to the Phase 2 formulation.
- Trial name
- B1371026 (NCT03130556)
- Testing
- Glasdegib, High Fat, High Calorie Meal, Rabeprazole
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteer
A Pharmacokinetic Study in Healthy Participants to Assess the Pharmacokinetics and Safety of a Supratherapeutic Dose of PCI-32765 (Ibrutinib) Capsule and Solution Formulations Administered With Food
The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) in healthy adult volunteers.
- Trial name
- NCT01969266
- Testing
- Treatment A: PCI-32765, Treatment B: PCI-32765
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the…
- Trial name
- NCT04445090
- Testing
- BI 1569912
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses
The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate…
- Trial name
- NCT07063342
- Testing
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Trospium Chloride
- Where
- United Kingdom
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release Formulation
The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and Food effect on the pharmacokinetics of sarpogrelate CR.
- Trial name
- NCT01841086
- Testing
- Anplag, UI03SPG300CT
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Korea United Pharm. Inc.
Healthy Volunteer
A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers
This single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers.
- Trial name
- NCT01665976
- Testing
- RO4917838, RO4927838
- Where
- France
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumors, Lymphoma
Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas
The purpose of this study is to evaluate the effect of food on the single-dose pharmacokinetics (PK) of alisertib administered as an enteric-coated tablet (ECT) formulation in participants with advanced solid tumors or lymphomas.
- Trial name
- NCT01898078
- Testing
- Alisertib
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- Millennium Pharmaceuticals, Inc.