Clinical trials: Food Labeling
Gout
Food Effect Study of Febuxostat XR in Healthy Participants
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40…
- Trial name
- NCT02374164
- Testing
- Febuxostat XR
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Advanced Solid Tumors
Study of MLN8237 in Participants With Advanced Solid Tumors
The purposes of this study were to estimate the relative (Rel) bioavailability (BA) of an oral solution (OS) formulation of alisertib in reference to a powder-in-capsule (PIC) formulation, to characterize the effect of food on…
- Trial name
- NCT00962091
- Testing
- Alisertib
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Biological Availability
Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants.
The purpose of this study is to estimate the relative bioavailability (rBA) of nirmatrelvir/ritonavir oral powder in 3 different food vehicles relative to the Paxlovid® tablets under fasted condition in healthy adult…
- Trial name
- NCT05544786
- Testing
- Nirmatrelvir/ ritonavir, Nirmatrelvir/Ritonavir
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.
- Trial name
- NCT01490788
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Healthy Subjects
Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
- Trial name
- NCT04150224
- Testing
- PBTZ169 640 mg OD, PBTZ169 640 mg BiD, PBTZ169 960 mg SD
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Hyperkalemia
Patiromer With or Without Food for the Treatment of Hyperkalemia
The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high…
- Trial name
- TOURMALINE (NCT02694744)
- Testing
- patiromer
- Where
- 29 sites in United States
- Volunteers
- 114 people
- Sponsor
- Relypsa, Inc.
Healthy
Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers
To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral…
- Trial name
- NCT02044367
- Testing
- Dabigatran etexilate
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Peanut Allergy
Safety Study of Viaskin Peanut to Treat Peanut Allergy
This study evaluates the safety of Viaskin Peanut 250 µg in the treatment of peanut allergy in children from 4 to 11 years of age.
- Trial name
- REALISE (NCT02916446)
- Testing
- Viaskin Peanut 250 µg
- Where
- 32 sites in United States, Canada
- Volunteers
- 393 people
- Sponsor
- DBV Technologies
no Condition
A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers
Primary objective: to investigate the effect of food on the bioavailability of DF 2156Y after single dose administration of 400 mg of ladarixin to healthy male and female volunteers under fed and fasting conditions.
- Trial name
- NCT04854642
- Testing
- Ladarixin
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dompé Farmaceutici S.p.A
Infections, Bacterial
To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.
This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted [RC] and high shear wet granulation [HSWG])…
- Trial name
- NCT02853435
- Testing
- Gepotidacin RC Tablet, Gepotidacin HSWG Tablet, Gepotidacin Capsule
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate…
- Trial name
- NCT02068690
- Testing
- BI 425809 PfOS, BI 425809 tablet
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers, Schizophrenia
Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2.
- Trial name
- NCT02748694
- Testing
- TAK-041
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Advanced Solid Tumors
An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820 to Determine the Maximum Tolerated Dose Following Twice Daily Oral Administration in Subjects With Unresectable Solid Tumors
This study consists of two Parts. Part A (Food Effect Study) and Part B (Determination of Maximum Tolerated Dose [MTD] for twice daily [BID] Dosing).Part A will be initiated first, and Part B will be initiated after the PK…
- Trial name
- NCT01773421
- Testing
- E7820
- Where
- 6 sites in Netherlands, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Eisai Inc.
Healthy
A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food
The main objective of this trial is to investigate the potential effect of food on the pharmacokinetics of BI 425809 following administration of the intended Commercial Formulation (iCF) with food (Test treatment, T) and without…
- Trial name
- NCT05347004
- Testing
- BI 425809
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood.
The primary objective of the single-rising dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730460 in healthy subjects following oral administration of single rising doses.
- Trial name
- NCT03483077
- Testing
- BI 730460
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food
The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R).
- Trial name
- NCT04789291
- Testing
- BI 1595043
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer
A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.
This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group 2) on the single oral dose pharmacokinetics of alectinib in healthy volunteers.
- Trial name
- NCT02023125
- Testing
- Alectinib, Esomeprazole, High Fat and Calorie Meal
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
Evaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential
This study will be an open-label, randomized, three-period, six-sequence crossover study of GDC-9545 administered to healthy females of non-childbearing potential to determine the relative bioavailability of the Phase 3 capsule…
- Trial name
- NCT04274075
- Testing
- GDC-9545 Tablet, Fasted: Treatment A, GDC-9545 Capsule, Fasted: Treatment B, GDC-9545 Capsule, Fed: Treatment C
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy
A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects
The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.
- Trial name
- NCT02372344
- Testing
- AZD0585
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pharmacokinetics
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
Grapefruit juice is an inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the enzyme systems responsible for the metabolism of colchicine.
- Trial name
- NCT00984009
- Testing
- Colchicine, Grapefruit Juice
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.