Clinical trials: Sub-healthy
Healthy
Topiramate 25 mg Capsules Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg capsules (test) versus Topamax® (reference) administered as 2 x 25 mg capsules under fasting conditions.
- Trial name
- NCT00905164
- Testing
- Topiramate Capsules, 25 mg, Topamax® Capsules, 25 mg
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company…
- Trial name
- NCT01247272
- Testing
- Fluoxetine Hydrochloride, PROZAC WEEKLY®
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Tobacco Use Disorder
A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 2 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 2 mg) in healthy smokers under fasting…
- Trial name
- NCT03541044
- Testing
- Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Terbinafine HCl 250 mg Tablet Under Fasting Conditions
The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in…
- Trial name
- NCT00833586
- Testing
- Terbinafine HCl 250mg tablets, Lamisil® 250 mg Tablets
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study
The purpose of this study was to assess bioequivalence (BE) of newly developed Glucophage® XR (GXR) reduced mass (RM) tablet (metformin hydrochloride 500 milligrams (mg) test tablet) and marketed Glucophage ® XR tablet (metformin…
- Trial name
- NCT04684420
- Testing
- Glucophage® XR RM Test, Glucophage® XR Reference
- Where
- South Korea
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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
Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting
The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL…
- Trial name
- NCT00835549
- Testing
- Cefdinir for oral suspension 250 mg/5mL, OMNICEF® for oral suspension 250 mg/5mL
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Pain
A Bioequivalence Study of Advil PM Liqui-Gels Minis (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) Compared to the Current Marketed Advil PM Liqui-Gels (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) in Healthy Adult Subjects Under Fasted Conditions
The purpose of this study is to support the submission of Advil PM Liqui-Gels Minis (ibuprofen/diphenhydramine hydrochloride 200 milligrams [mg]/25 mg) which is a size reduction of the currently marketed Advil PM Liqui-Gels, by…
- Trial name
- NCT05674721
- Testing
- Advil PM Liqui-Gels Minis, Advil PM Liqui-Gels
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- HALEON
Healthy
An Interaction Study to Assess Drug Levels in Fasting Healthy Adult Subjects
To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir.
- Trial name
- NCT00802074
- Testing
- Raltegravir, Fosamprenavir, Ritonavir
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Garden State Infectious Disease Associates, PA
Relapsing Remitting Multiple Sclerosis
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve…
- Trial name
- NCT04570670
- Testing
- monomethyl fumarate 190 mg, dimethyl fumarate 240 mg
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Healthy
Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting 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 fasting conditions.
- Trial name
- NCT00836056
- Testing
- Clindamycin 300 mg capsule, Cleocin HCl 300 mg capsules
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
- Trial name
- NCT02014272
- Testing
- RIN 150, reference drugs
- Where
- Singapore
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Healthy
Amlodipine 10 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amlodipine from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc® 10 mg Tablets under fasting conditions.
- Trial name
- NCT00841542
- Testing
- Amlodipine Besylate, Norvasc®
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers
The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions.
- Trial name
- NCT06122194
- Testing
- Drug: PF-07817883
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Therapeutic Equivalency
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
A single center, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma…
- Trial name
- AZA (NCT03930264)
- Testing
- Azathioprine 50Mg Tab, Azathioprine 10mg/mL oral suspension
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nova Laboratories Limited
Healthy
Venlafaxine 25 mg Tablets Under 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 fasting conditions.
- Trial name
- NCT00834964
- Testing
- Venlafaxine 25 mg Tablets, Effexor® 25 mg Tablets
- Where
- 2 sites in Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
Fasting Bioavailability Study of Zonisamide Capsules
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral…
- Trial name
- NCT00685139
- Testing
- Zonisamide 100 mg Capsule, Zonisamide (Zonegran®) 100 mg Capsule
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.