Clinical trials: Fed Conditions
Healthy
Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions
The objective of this study is to compare the rate and extent of absorption of two Tramadol Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites, administered as 1 x 300 mg controlled-release…
- Trial name
- NCT00834912
- Testing
- Tramadol hydrochloride, Tramadol HCl
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Labopharm Inc.
Healthy
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc.
- Trial name
- NCT00759915
- Testing
- morphine sulfate extended-release capsules, KADIAN (morphine sulfate extended-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects
The primary objective of this trial is to investigate the effect of food on the pharmacokinetics of the oral tablet formulation of BI 1015550 by investigating the relative bioavailability of TF1 under fed and fasted conditions.
- Trial name
- NCT03302078
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Anastrozole 1 mg Tablets Under Fed Conditions
The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals, USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in…
- Trial name
- NCT01183390
- Testing
- Anastrozole
- Where
- Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male and female volunteers under fed conditions
- Trial name
- NCT02577315
- Testing
- Empagliflozin, Metformin
- Where
- Russia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Trandolapril 4 mg Tablet Under Non-Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between trandolapril 4 mg tablets (test) and Mavik® 4 mg Tablets (reference) after a single-dose in healthy subjects under fed conditions.
- Trial name
- NCT00840073
- Testing
- Trandolapril 4 mg Tablets, Mavik® 4 mg Tablets
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
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 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
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
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.
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
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