Clinical trials: Food Labeling
Healthy Volunteers
A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation
The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK following single oral administration of TAK-536 pediatric formulation in Japanese healthy adult male participants.
- Trial name
- NCT03434977
- Testing
- TAK-536
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Bioavailability
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
This is a single center, Phase 1, randomized, open-label, single-dose, 4 treatment, 4-period, 4-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin from the Test and Reference products, and to…
- Trial name
- NCT06481709
- Testing
- RLF-OD032, Kuvan
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Healthy Participants
A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants
The purpose of the study is to estimate the relative bioavailability of a new minzasolmin tablet formulation versus reference 'granules in capsule' formulation in healthy participants and to evaluate the effect of food with the…
- Trial name
- NCT06533475
- Testing
- Minzasolmin tablet formulation under fasting condition, Minzasolmin Granules in capsule under fasting condition, Minzasolmin tablet formulation under fed condition
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
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.
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
Denture Retention
A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers
The purpose of this study is to evaluate a methodology to determine the ability of a denture adhesive to restrict food ingress underneath dentures during eating.
- Trial name
- NCT03345108
- Testing
- Denture Adhesive Cream (Conventional Application), Denture Adhesive (Continuous Strip Application), No Adhesive
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
- Trial name
- NCT02129192
- Testing
- Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet, T80/A5/H12.5 mg FDC tablet
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men
The main objective of this trial is to assess the effect of food on the pharmacokinetics of an oral tablet formulation of BI 1323495 by investigating the relative bioavailability following single dose administration under fed and…
- Trial name
- NCT03802331
- Testing
- BI 1323495,
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Food Preferences
Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction
Sugar-sweetened beverages are a significant contributor to adult and childhood obesity in Guatemala. Policies to place health warning labels on sugar-sweetened beverages are being pursued, but there is little empirical data on…
- Trial name
- NCT04022694
- Testing
- Exposure to beverage health information, Exposure to beverage calorie information
- Where
- Guatemala
- Volunteers
- 628 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Healthy Volunteers
Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects
The primary objective of this trial is to investigate the relative bioavailability of BI 1467335, given as film-coated tablet compared to BI 1467335, given as oral solution.
- Trial name
- NCT02999191
- Testing
- BI 1467335 (Treatment A), BI 1467335 (Treatment B), BI 1467335 (Treatment C)
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants
The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.
- Trial name
- NCT05134350
- Testing
- LOXO-305, Omeprazole
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Loxo Oncology, Inc.
Healthy Volunteers, Adult
A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants
The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults.
- Conditions
- Healthy Volunteers, Adult, Pharmacokinetics
- Trial name
- NCT05852340
- Testing
- Ritlecitinib
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood
BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market.
- Trial name
- NCT05380947
- Testing
- BI 1810631 - trial formulation 1 (TF1), BI 1810631 - new formulation (NF), Rabeprazole sodium
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the…
- Trial name
- NCT04445090
- Testing
- BI 1569912
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Healthy Volunteers
Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study
The purpose of this study is to characterize the safety, tolerability and plasma pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral suspension doses at escalating dose levels in healthy…
- Trial name
- NCT02461160
- Testing
- TAK-915 suspension, Midazolam, TAK-915 tablet
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood
This trial investigates whether food influences the amount of BI 3731579 in the blood.
- Trial name
- NCT06861829
- Testing
- BI 3731579
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Autism Spectrum Disorder
A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers
This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
- Trial name
- NCT04156646
- Testing
- Balovaptan, Esomeprazole
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche