Clinical trials: Food Labeling
Healthy Volunteers
A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants
The Purpose of this study is to assess the relative bioavailability, dose proportionality, the impact of food on the rate and extent of absorption, palatability of the selected pediatric formulation of maribavir and the safety…
- Trial name
- NCT04131556
- Testing
- Maribavir
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Shire
Healthy
Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects
- Trial name
- NCT01703858
- Testing
- BI 113608 PIB, BI 113608, pantoprazole 40 mg STADA
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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 Volunteers
Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers
Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.
- Trial name
- NCT01890785
- Testing
- Lisdexamfetamine Dimesylate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shire
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
Malignant Melanoma
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E…
- Trial name
- NCT01264380
- Testing
- RO5185426
- Where
- 10 sites in United States
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Healthy
Study of Single and Multiple Ascending Doses of PF-07059013 in Healthy Adult Participants
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) of single and multiple ascending oral doses of PF-07059013 in healthy adult participants.
- Trial name
- NCT04323124
- Testing
- PF-07059013
- Where
- Belgium
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Pfizer
Attention Deficit Hyperactivity Disorder
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
This study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with Attention-Deficit Hyperactivity…
- Trial name
- NCT00428792
- Testing
- Methylphenidate 20 mg long-acting capsules
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Novartis
Healthy
A Food-Drug Interaction Study of Serum Urate After Oral Inosine
The purpose of this study is to assess the effects of food on the amount of urate in the body after a single oral dose of inosine.
- Trial name
- NCT02614469
- Testing
- Inosine
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Michael Alan Schwarzschild
Healthy
Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects
The purpose of this trial is to investigate the effect of food with different fat content and of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative bioavailability of deleobuvir.
- Trial name
- NCT01983566
- Testing
- BI 207127 high fat, BI 207127 with Omeprazole, BI 207127
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pharmacokinetics of Mirabegron, Food Effect
A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants
This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of mirabegron in healthy Chinese male and female participants.
- Conditions
- Pharmacokinetics of Mirabegron, Food Effect, Healthy Chinese Subjects
- Trial name
- NCT04501640
- Testing
- mirabegron
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma China, Inc.
Healthy Participants
Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule
This study is intended to estimate the bioavailability of a single 100 mg bosutinib capsules relative to four 25 mg capsules under fed condition in adult healthy participants and to estimate the effect of a high-fat, high-calorie…
- Trial name
- NCT05032690
- Testing
- Bosutinib capsule, Bosutinib
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Neoplasm, Advanced or Metastatic
A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants
The purpose of this study is to evaluate the relative bioavailability of a new tablet formulation of TAK-117 (new clinical trial material [NTM]) compared to the TAK-117 Process B capsules (current clinical trial material [CTM])…
- Trial name
- NCT02625259
- Testing
- TAK-117, Lansoprazole
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy
A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood
The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI…
- Trial name
- NCT05945888
- Testing
- BI 3000202
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hypertension
8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.
- Trial name
- NCT01570686
- Testing
- Aliskiren
- Where
- 83 sites in United States, Canada and 5 more
- Volunteers
- 589 people
- Sponsor
- Novartis Pharmaceuticals