Clinical trials: Food Labeling
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food
The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses.
- Trial name
- NCT04801693
- Testing
- BI 1819479
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Migraine
Study on the Pharmacokinetics (PK) of DFN-15 vs Comparator and Food-effect on DFN-15 PK in Healthy Adult Subjects
An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 under fasting conditions versus Comparator under fed conditions and to determine food-effect of DFN-15 in Healthy Adult Subjects
- Trial name
- NCT03282838
- Testing
- DFN-15 (fasted), DFN-15 (fed), Comparator Celebrex® (fed)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Mixed Dyslipidemia
The Food Effect on PK Characteristics and Safety Profiles of PA-111
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.
- Trial name
- NCT06976489
- Testing
- PA-111
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Solid Tumours
Phase I Study to Assess the Effect of Food on AZD1775 Pharmacokinetics in Patients With Advanced Solid Tumours
The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a single dose of AZD1775 (printed capsules) in patients with advanced solid tumours.
- Trial name
- NCT03315091
- Testing
- Treatment A - AZD1775 administered under fasted conditions, Treatment B - AZD1775 administered under fed conditions.
- Where
- 7 sites in France, Netherlands and 1 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Healthy
Study of the Effect of Food Intake on the Bioavailability of XC8 10 mg Film-coated Tablets
Primary objective of the study: evaluation of the effect of food intake on the bioavailability of XC8, film-coated tablets, 10 mg after a single oral administration in fed or fasted condition at a dose of 20 mg (two tablets).
- Trial name
- NCT05294250
- Testing
- XC8
- Where
- Russia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Healthy Volunteers
A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults
The purpose of this study is to evaluate the relative bioavailability of apremilast once-daily formulation relative to a twice daily formulation when administered as multiple doses (Part 1), and when administered as a single dose…
- Trial name
- NCT02777554
- Testing
- Apremilast IR, Apremilast XL
- Where
- 2 sites in United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Amgen
Obesity
Does Food Labeling Influence Long-term Food Intake and Eating-related Variables in Women?
Weight management is a critical issue in developed countries where the prevalence of obesity is always increasing. While the mismatch of energy intake and energy expenditure is recognized as a leading cause of obesity, knowledge…
- Trial name
- MENU (NCT01604954)
- Testing
- Nutrient-label, Calorie-label, No label
- Where
- Canada
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Laval University
Healthy
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
The main objectives of the SRD part of this trial are to investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1356225 in healthy male subjects following oral administration of single rising…
- Trial name
- NCT04065295
- Testing
- BI 1356225
- Where
- Germany
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
The primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy…
- Trial name
- NCT05988021
- Testing
- CCX168
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Amgen
Peanut Allergy
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: To assess the efficacy of Viaskin Peanut after up to 36…
- Trial name
- OLFUS-VIPES (NCT01955109)
- Testing
- Viaskin Peanut 250 mcg
- Where
- 22 sites in United States, Canada and 2 more
- Volunteers
- 171 people
- Sponsor
- DBV Technologies
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
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.
Healthy
Lofexidine Food Effect Study in Healthy Volunteers
The objective of this single-dose, open-label, randomized, two-period, two-way crossover, food-effect study is to evaluate the effect of food on the rate of absorption and oral bioavailability of a test formulation of lofexidine…
- Trial name
- NCT01437306
- Testing
- Lofexidine HCl
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Healthy Volunteer
Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults
The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.
- Trial name
- NCT01634178
- Testing
- Apremilast
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Amgen
Osteoarthritis
Bioavailability Study With GLPG1972
This is an open-label study to determine the pharmacokinetics of a new tablet formulation of GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human study (GLPG1972-CL-101).
- Trial name
- NCT02851485
- Testing
- GLPG1972 600 mg oral solution fasted, GLPG1972 600 mg oral tablet fasted, GLPG1972 600 mg oral tablet fed
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Hypertension
Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects
This study are (1) to assess the relative bioavailability (BA) of a single oral dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine Besylate Tablet (NORVASC®) from Pfizer Inc.
- Trial name
- NCT03657550
- Testing
- Levamlodipine, Amlodipine, Amlodipine, Levamlodipine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Conjupro Biotherapeutics, Inc.
Undernutrition, Elderly Person
Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups
Food is available in easy-to-grip bites that allow residents in care settings to use their fingers for food. This new way of eating can help limit weight loss, increase food intake, gain independence and improve the enjoyment of…
- Trial name
- PLAID (NCT05389098)
- Testing
- Hand-Eating, Control
- Where
- 2 sites in France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Hospital, Tours
Healthy
A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food
Single-rising dose (SRD) part The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1815368 in healthy male subjects following oral administration of single…
- Trial name
- NCT05337592
- Testing
- BI 1815368 formulation 1, BI 1815368 formulation 2
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hypertension
A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet
This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.
- Trial name
- NCT02348658
- Testing
- TAK-536TCH
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
Effect of Food on the Oral Bioavailability of a Prolonged-release Formulation of Vamifeport in Healthy Adults
This is a phase I, single-center, randomized, open-label, single-dose, 2-way, 2-period, crossover study to evaluate the effect of food on the pharmacokinetics (PK) of vamifeport prolonged-release (PR) formulation in healthy adult…
- Trial name
- NCT06996184
- Testing
- Vamifeport (PR formulation)
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- CSL Behring