Clinical trials: Fed Conditions
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Venlafaxine 25 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of venlafaxine 25 mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fed conditions.
- Trial name
- NCT00834249
- Testing
- Venlafaxine 25 mg Tablets, Effexor® 25 mg Tablets
- Where
- 2 sites in Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Ursodiol 500 mg Tablets Under Fed Conditions
The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference)after a single-dose in healthy subjects under fed conditions.
- Trial name
- NCT00909753
- Testing
- Ursodiol, Urso Forte™
- Where
- Canada
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
- Trial name
- NCT00939367
- Testing
- Zolpidem Tartrate Tablets 10 mg, 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet
The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg caffeine against 400 mg ibuprofen alone under fed conditions
- Trial name
- NCT02629354
- Testing
- Ibuprofen, Caffeine
- Where
- South Africa
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone extended release tablets) under fed and fasting conditions.
- Trial name
- NCT02465489
- Testing
- Deferiprone extended release, Deferiprone immediate release
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ApoPharma
Healthy
A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood
The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1358894 administered as tablet formulation 2 (TF2a, TF2b) under fasted conditions compared with the tablet formulation 1 (TF1)…
- Trial name
- NCT03892616
- Testing
- BI 1358894 (B), BI 1358894 (C), BI 1358894 (D)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 180 mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.
- Trial name
- NCT00835640
- Testing
- Fexofenadine 180 mg tablets, ALLEGRA® 180 mg tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fed Bioequivalence Study of Fenofibric Acid Versus TriCor® (Fenofibrate)
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition.
- Trial name
- NCT00960687
- Testing
- Fenofibric Acid (Fibricor™) 105 mg Tablet, Fenofibrate (Tricor®) 145 mg Tablet
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects
The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a…
- Trial name
- NCT02821338
- Testing
- Lamotrigine Extended Release
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Bioequivalence, Fixed Dose Combination Tablets
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
- Conditions
- Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
- Trial name
- NCT02637037
- Testing
- dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation…
- Trial name
- NCT00830219
- Testing
- Ropinirole HCl 0.25 mg Tablets, Requip® 0.25 mg Tablets
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.
- Trial name
- NCT00849797
- Testing
- Oxcarbazepine, Trileptal®
- Where
- Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin
- Trial name
- NCT01581931
- Testing
- Linagliptin/metformin, Metformin, Linagliptin
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hereditary Tyrosinemia, Type I
Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)
The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions (food-effect).
- Trial name
- NCT02750332
- Testing
- Nitisinone
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Healthy
A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine Sulphate 300 mg tablets, manufactured by the…
- Trial name
- NCT00727272
- Testing
- Quinine Sulfate Capsules 324 mg, Quinine Sulphate Tablets 300 mg
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Cefprozil 500 mg Tablets Under Fed Conditions
The objective of this study is to compare the relative bioavailability of cefprozil 500 mg tablets with that of Cefzil 500 mg tablets in healthy, non-smoking adults under non-fasting conditions.
- Trial name
- NCT00840866
- Testing
- cefprozil, Cefzil®
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Childhood Obesity, Infant Development
Unintentional Overfeeding of Formula Fed Infants
Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants in the U.S. are fed infant formula.
- Trial name
- Whoa Baby (NCT02701868)
- Where
- United States
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Healthy
Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption if amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference),administered as 1 x 10 mg- 20 mg capsule under fed conditions.
- Trial name
- NCT00835367
- Testing
- Amlodipine-benazepril 10 mg-20 mg capsules, Lotrel® 10 mg-20 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions
The purpose of this study is to assess the bioequivalence between Amoxicillin/Clavulanate Potassium Oral Suspension 600/42.9 mg/5 mL and Augmentin ES-600 Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects…
- Trial name
- NCT00840840
- Testing
- 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL, Augmentin ES-600™
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA