Clinical trials: Food Labeling
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
Advanced Solid Tumor
A Phase 1 Study of BB3008 in Participants With Advanced Solid Tumors
This is a Phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics, efficacy and preliminary food effect of BB3008 as monotherapy in subjects with advanced solid tumors.
- Trial name
- NCT06143007
- Testing
- BB3008 tablet
- Where
- 2 sites in China
- Volunteers
- 42 people
- Sponsor
- Broadenbio Ltd., Co.
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
Bioavailability Study of K0706 in Healthy Subjects
This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted…
- Trial name
- NCT03316820
- Testing
- K0706
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sun Pharma Advanced Research Company Limited
HIV Infections
A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants
The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.
- Trial name
- NCT06368986
- Testing
- VH4011499 Dose A, VH4011499 Dose B
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
Healthy Participants
Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.
- Trial name
- NCT04390776
- Testing
- PF-06651600
- Where
- 2 sites in United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Participants
A Study to Assess the Effect of Food on the Drug Levels of Admilparant
The purpose of this study is to assess the effect of food on the drug levels of Admilparant
- Trial name
- NCT07225647
- Testing
- Admilparant
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Therapeutic Equivalency, Food
Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial…
- Trial name
- NCT00807118
- Testing
- Fesoterodine
- Where
- Japan
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers
The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the…
- Trial name
- NCT02160158
- Testing
- Fesoterodine ER (fasted), Fesoterodine SR3 (fasted), Fesoterodine SR3 (fed)
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Subjects
A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers
The purposes of this Phase 1 study of sevasemten are to: 1. Evaluate the effect of multiple-dose administration of verapamil on the single-dose of sevasemten in healthy adults 2.
- Trial name
- EDG-5506-102 (NCT06916897)
- Testing
- sevasemten, Verapamil
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Edgewise Therapeutics, Inc.
Healthy
Food Effect Study of VHX-896 in Healthy Volunteers
A single center, two-period, randomized study to evaluate the food effect of VHX-896 tablets in healthy volunteers
- Trial name
- NCT06803290
- Testing
- VHX-896
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Dyslipidemia, Healthy Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia.
- Trial name
- NCT01487460
- Testing
- TAP311
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Huntington Disease, Tardive Dyskinesia
Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets
This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164…
- Trial name
- NCT06474650
- Testing
- LPM3770164 sustained release tablet
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Ulcerative Colitis
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
This exploratory, open-label clinical study aims to explore the effects of KB295, a novel glycan, on adult patients with ulcerative colitis (UC) presenting with mild-to-moderate UC symptoms
- Trial name
- NCT04508413
- Testing
- KB295
- Where
- 3 sites in United States, Ireland
- Volunteers
- 12 people
- Sponsor
- Kaleido Biosciences
Hepatitis C
Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy…
- Trial name
- NCT02095860
- Testing
- DCV 3DAA FDC
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers
Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH> 4.0) following twice daily administration at different dosing times relative to food (30 or 60 minutes prior to food or…
- Trial name
- NCT00442208
- Testing
- PN 200
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- POZEN
Healthy
Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers
To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.
- Trial name
- NCT02161432
- Testing
- BI 187004
- Where
- Germany
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim