Clinical trials: Fed
Healthy
Levetiracetam 1000 mg Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of an investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the commercially available reference product under fed…
- Trial name
- NCT00859430
- Testing
- Levetiracetam, Keppra®
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Granisetron 1 mg Tablets, Non-fasting
The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects…
- Trial name
- NCT00834522
- Testing
- Granisetron hydrochloride 1 mg tablets, Kytril® 1 mg tablets
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Type 2 Diabetes Mellitus
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis)…
- Trial name
- NCT01068717
- Testing
- Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state), Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions
This is a single center, Phase 1, randomized, open-label, single-dose, 2 treatment, 2-period,2-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin between the Test and Reference products in…
- Trial name
- NCT06987773
- Testing
- RLF-OD032 100 mg/mL oral suspension, Kuvan 100 MG Powder for Oral Solution
- Where
- Canada
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Healthy
Clindamycin 300 mg Capsules in Healthy Subjects Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference, administered as 1 x 300 mg capsule under fed conditions.
- Trial name
- NCT00836004
- Testing
- Clindamycin 300 mg capsule, Cleocin HCl 300 mg capsules
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Mycophenolate Mofetil Tablets Under Fed Conditions
The objective of this study was to evaluate the comparative bioavailability between Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg Tablets (reference), after a single-dose in healthy subjects under fed…
- Trial name
- NCT00908128
- Testing
- Mycophenolate Mofetil, CellCept®
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
- Trial name
- NCT01099709
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy Subjects
Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted
Determine and compare the plasma concentrations of Mucinex® Extended Release (ER) 600 mg bi-layer tablet in normal healthy volunteers in fed and fasting conditions
- Trial name
- NCT03649750
- Testing
- Mucinex®
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser LLC
Erectile Dysfunction
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
- Trial name
- NCT01254396
- Testing
- Sildenafil
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Volunteer Study
Ibuprofen Suspension Bioequivalence Study
The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.
- Trial name
- NCT02503085
- Testing
- Nurofen for Children®, Algifor Dolo Junior®
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
Healthy
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc.
- Trial name
- NCT02465866
- Testing
- CL-108, Vicoprofen, Ultracet
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Charleston Laboratories, Inc
Healthy
A Study to Compare Different Preparations of Sisunatovir in Healthy Adult Participants.
The purpose of this study is to learn how different preparations of sisunatovir are taken up into the blood when taken on an empty stomach or with a meal in healthy adults.
- Trial name
- NCT05994963
- Testing
- sisunatovir
- Where
- Belgium
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diabetes Mellitus, Type 2
An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin, 10 mg + 1000 mg Versus the Combined Use of Forxiga™, 10 mg and Two Glucophage® Long, ER Tablets, 500 mg Co-administered to Healthy Volunteers Under Standard Fed Conditions
The aim of this study is to demonstrate bioequivalence of fixed dose combination Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg, (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin)…
- Trial name
- NCT02722239
- Testing
- Xigduo XR, Metformin ER (Glucophage® long), Dapagliflozin (Forxiga)
- Where
- Russia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus
Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets…
- Trial name
- NCT01365091
- Testing
- Saxagliptin/metformin fixed-dose combination (FDC), Saxagliptin, Metformin extended-release (XR)
- Where
- Brazil
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects.
- Trial name
- NCT02690727
- Testing
- RP6530
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Rhizen Pharmaceuticals SA
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6…
- Trial name
- NCT04014062
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Autoimmune Diseases
A Study to Compare the Pharmacokinetics (PK) of GSK2982772 Following Administration of Different Modified Release (MR) Formulations in Capsule and MR Tablet Formulations Relative to an Immediate Release (IR) Tablet Formulation and to Check the PK of MR Formulation in Capsule Following Repeat Doses
GSK2982772 is a first-in-class, highly selective, receptor-interacting protein-1 (RIP1) kinase inhibitor being developed for the treatment of inflammatory bowel disease, plaque psoriasis (PsO), rheumatoid arthritis (RA) and other…
- Trial name
- NCT03266172
- Testing
- GSK2982772 Modified Release, GSK2982772 Immediate Release
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Arthritis, Rheumatoid
First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699
This FTIH study, intends to identify the doses of GSK3358699, which are well tolerated by the subjects whilst delivering a robust pharmacodynamic (PD) response.
- Trial name
- NCT03426995
- Testing
- GSK3358699, GM-CSF, LPS
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy, Therapeutic Equivalency
Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed…
- Trial name
- NCT00658541
- Testing
- Zolpidem Tartrate 10 mg tablet, Zolpidem Tartrate 10 mg tablet (Ambien®)
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Chronic Kidney Disease
A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition
This study is intended to assess the relative bioavailability between the (extended-release) ER8 capsule formulation (the formulation that is currently used for verinurad development) given under fasted conditions and 2 new…
- Trial name
- NCT04024501
- Testing
- Verinurad ER8 capsule formulation (fasted), Verinurad A-capsule formulation (fasted), Verinurad A-capsule formulation (fed)
- Where
- Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- AstraZeneca