Clinical trials: Food Labeling
Chronic Pain
To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mg
An open-label, randomized, 3-way crossover study to evaluate the pharmacokinetics of investigational product "Ibuprofen Modified-Release Tablets 800 mg" in comparison to the reference standard "Ibuprofen Regular-Release Tablets…
- Trial name
- NCT05329454
- Testing
- Ibuprofen Tablets
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Overseas Pharmaceuticals, Ltd.
Healthy Adults
A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib
An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
- Trial name
- NCT04800614
- Testing
- sitravatinib
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mirati Therapeutics Inc.
Neoplasms, Cancer
Bioavailability and Food Effect Study of TKI258 (CSF Capsules vs. FMI Capsules)in Adult Patients With Advanced Solid Tumors
This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor
- Conditions
- Neoplasms, Cancer, Tumors
- Trial name
- NCT01030055
- Testing
- TKI258 (dovitinib)
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Gastrointestinal Cancer
To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal…
- Trial name
- NCT05606848
- Testing
- Nutrition Emulsion (TPF-T), Foods for special medical purposes [FSMP] for patients with tumors
- Where
- 14 sites in China
- Volunteers
- 350 people
- Sponsor
- Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Healthy
Relative Bioavailability DS-1971a Suspension and Tablets and Food Effect on DS-1971a Tablets
This is an open label, randomised, 3 treatment, 3 period crossover study. This study is designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a reconstituted oral suspension and the effect of a…
- Trial name
- NCT02266940
- Testing
- DS-1971a suspension, DS-1971a tablet
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Acne
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.
- Trial name
- NCT02457520
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Healthy
A Study of JNJ-64140284 Solid Dose Formulations in Healthy Male Participants
The purpose of this study is to compare the pharmacokinetic profile of a single dose of two solid dosage formulations relative to a reference formulation (solution in polyethylene glycol-400 [PEG-400]) of JNJ-64140284 in healthy…
- Trial name
- NCT04033458
- Testing
- JNJ-64140284
- Where
- Belgium
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers, Nitric Oxide
Evaluation of Adding Nitrate Into Foods for Regulating Nitric Oxide Bioavailability in Healthy Individuals
Inorganic nitrate, found in leafy green vegetables and beetroot, can help lower blood pressure and support heart health. Early experimental work has suggested that dietary nitrate supplementation, in the form of beetroot juice or…
- Conditions
- Healthy Volunteers, Nitric Oxide, Vascular Function
- Trial name
- NCT07172425
- Testing
- Inorganic potassium nitrate-fortified biscuits supplementation, Inorganic potassium nitrate-fortified cereal bar supplementation, Inorganic potassium nitrate-fortified porridge supplementation
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Queen Mary University of London
Cow Milk Allergy, Food Allergy
Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy
Cow's milk protein allergy (CMPA) is one of the most common food allergies in early childhood. The first-line treatment of CMPA is the elimination of cow's milk proteins (CMPs) from the child's or maternal diet.
- Trial name
- NCT06664918
- Testing
- oral food challenge (OFC)
- Where
- 2 sites in Poland
- Volunteers
- 92 people
- Sponsor
- Medical University of Warsaw
Healthy Subjects
Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.
GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain.
- Trial name
- NCT00536497
- Testing
- GW842166X
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers
The purpose of this study is to compare the bioavailability of CMX001 when administered as a tablet vs a solution and to determine the effect of a high-fat meal on CMX001 bioavailability.
- Trial name
- NCT00780182
- Testing
- CMX001
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Healthy
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers
Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
- Trial name
- NCT01541488
- Testing
- BI 1021958
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Gastrointestinal Discomfort, Digestive Well Being
Evaluation of Gut-Related Well-Being and Mood Effects of a Daily Nutritional Food Ingredient From the Co-Fermentation of Fungal Mycelium (Pleurotus Pulmonarius) and Microalgae (Chlorella Vulgaris)
The purpose of the study is to evaluate the gut-related well-being and mood effects of a food ingredient obtained from the co-fermentation of oyster mushroom mycelium (Pleurotus pulmonarius), microalgae (Chlorella vulgaris), and…
- Conditions
- Gastrointestinal Discomfort, Digestive Well Being, Gut-related Symptoms
- Trial name
- NCT07407777
- Testing
- Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Koralo GmbH
Healthy
A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food
The aim of this trial is to establish bioequivalence between EU-, US- and Japan-sourced Otezla® tablet formulations to assure comparability of results from Phase III trials of BI 730357 (new oral agent for treatment of psoriasis…
- Trial name
- NCT04811573
- Testing
- EU-sourced Otezla®, US-sourced Otezla®, Japan-sourced Otezla®
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Food and Ethnicity Effects on Pharmacokinetics and Safety of JPI-547 in Healthy Male Participants
This study aims to evaluate the effects of food or ethnicity on the pharmacokinetics and safety/tolerability of JPI-547 after a single oral administration in healthy male Korean, Caucasian, and Chinese participants.
- Trial name
- NCT07570186
- Testing
- JPI-547
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Onconic Therapeutics Inc.
Sarcoma
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms…
- Trial name
- NCT01896505
- Testing
- KCP-330
- Where
- 2 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Karyopharm Therapeutics Inc
Soil-transmitted Helminth Infection, Onchocerciasis (River Blindness)
A Study to Learn About How Much Emodepside Gets Absorbed in the Blood and How Food Affects Its Absorption When Given as a New Type of Tablet to Healthy Participants
Onchocerciasis or river blindness is an infectious disease caused by a parasitic worm. It spreads through the bite of an infected blackfly.
- Trial name
- NCT06412926
- Testing
- BAY 44-4400
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Adult Participants
Evaluation of BRC-002 Safety, Tolerability, Pharmacokinetics, and Food Effects in Healthy Participants
This study will evaluate the safety and tolerability of BRC-002, an investigational botanical drug from cannabis, in healthy adults.
- Trial name
- NCT07699120
- Testing
- BRC-002
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Biopharmaceutical Research Company
Alzheimer's Disease
An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption
This study will be a single-center, open-label, randomized, 3-treatment crossover study of single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet formulation administered under fed and…
- Trial name
- NCT01716897
- Testing
- E2609
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy
A Study to Investigate the Effect of Food on the Pharmacokinetics of IN-A002 Capsule in Healthy Male Subjects
This study aims to investigate the effect of food on the pharmacokinetics of IN-A002 capsule in healthy male subjects
- Trial name
- NCT05019755
- Testing
- IN-A002(IN-115314) capsule
- Where
- South Korea
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation