Clinical trials: Food Labeling
Healthy Subjects
A Dose Escalation and Food Effect Study of SKLB1028 in Healthy Subjects
The purpose of this study was to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of SKLB1028 in healthy subjects. This study has also explored the effect of food on the PK of SKLB1028.
- Trial name
- NCT05109663
- Testing
- SKLB1028
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Opioid Substitution Treatment
Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution
A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption
- Trial name
- NCT02773316
- Testing
- MR902, IR morphine sulphate
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Mundipharma Research Limited
Healthy Volunteers
A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects.
This study will estimate the relative bioavailability of AZD5055 film-coated tablet as compared to AZD5055 oral suspension. The study will also assess the absolute bioavailabilty of AZD5055 and the effect of food and an acid…
- Trial name
- NCT05630677
- Testing
- AZD5055 solution for infusion, AZD5055 oral suspension, AZD5055 film-coated tablet
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers
To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers
- Trial name
- NCT05712681
- Testing
- JP-1366 20mg tablet
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Onconic Therapeutics Inc.
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.
Influenza
A Study to Assess the PK of AL-794 Formulations in Healthy Subjects
This study is a single-center, randomized, open-label crossover study to assess the pharmacokinetics and food effect of AL-794 formulations in healthy subjects.
- Trial name
- NCT02877160
- Testing
- AL-794 suspension, AL-794 tablet
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Healthy, Fasting
The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers
This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under…
- Conditions
- Healthy, Fasting, Fed
- Trial name
- NCT07396844
- Testing
- Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
- Where
- Thailand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- LG Chem
Cystic Fibrosis
A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.
- Trial name
- NCT01899105
- Testing
- lumacaftor, ivacaftor
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Prostatic Hyperplasia
A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry.
This study will be an open-label, randomized, single dose, two-period crossover study to determine the bioavailability of a fixed dose combination capsule formulation of dutasteride and tamsulosin hydrochloride (0.5mg/0.2mg)…
- Trial name
- ARI114694 (NCT01254071)
- Testing
- Dutasteride (0.5mg); Tamsulosin hydrochloride (0.2mg); fixed dose combination product of duatsteride (0.5mg) and tamsulosin hydrochloride (0.2mg)
- Where
- Australia
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
The Bioavailability of a Spray Dried Dispersion Solid Dose Formulation of PF-06260414 Relative to a Suspension Formulation
The current study will investigate the relative bioavailability of a spray dried dispersion solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF 06260414 relative to a single oral dose of 30 mg…
- Trial name
- NCT02393807
- Testing
- PF 06260414 solid dose formulation, PF-06260414 nanosuspension
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Hepatitis C
Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072
To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days.
- Trial name
- NCT00982826
- Testing
- ABT-072
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Abbott
HIV Infections
A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults
The aim of the study is to gather information on how the drug behaves in healthy adults, how it is absorbed, and how it interacts when taken with other medicines.
- Trial name
- NCT07066722
- Testing
- VH4524184, Itraconazole, Rifabutin
- Where
- 2 sites in United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435
The purpose of this study is to investigate the effect of food on the pharmacokinetics (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male participants.
- Trial name
- NCT01799603
- Testing
- TMC435
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Dyslipidemias
A Clinical Trial to Assess the Effects of Food on the Bioavailability of CKD-337
A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects
- Trial name
- NCT03382756
- Testing
- High fat diet, CKD-337
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
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
Healthy Volunteers
Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101.
The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN1101 in…
- Trial name
- NCT03340220
- Testing
- XPF-008, Microcrystalline Cellulose, XPF-010
- Where
- United Kingdom
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Xenon Pharmaceuticals Inc.
Healthy Volunteers
A Study of the Safety, Tolerability, and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants
The purpose of this study is to assess the effect of food on the bioavailability of venglustat and to assess the relative bioavailability of venglustat tablet swallowed whole with water versus a tablet chewed and then swallowed…
- Trial name
- NCT06418620
- Testing
- Venglustat
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Sanofi
Parkinson Disease
A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease
This trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety, tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease.
- Trial name
- NCT04295642
- Testing
- CVL-751
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Cerevel Therapeutics, LLC