Clinical trials: Sub-healthy
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
Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial…
- Trial name
- NCT00833664
- Testing
- Terbinafine HCl 250mg tablets, Lamisil® 250 mg Tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions
The objective of this study was to compare the oral bioavailability of an investigational formulation of mycophenolate mofetil (MMF) 250 mg capsules to an equivalent dose of the commercially available reference product, CellCept®…
- Trial name
- NCT00911274
- Testing
- Mycophenolate Mofetil, CellCept®
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions
This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating…
- Trial name
- NCT01260948
- Testing
- Donepezil Hydrochloride, Aricept®
- Where
- United States
- Volunteers
- 26 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
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy…
- Trial name
- NCT03566810
- Testing
- Test GXR, Reference GXR
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
Ursodiol Tablets 500 mg Under Fasting 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 fasting conditions.
- Trial name
- NCT00909610
- Testing
- Ursodiol, Urso Forte™
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Paroxetine Hydrochloride 40 mg Tablets Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 40 mg film-coated tablets (test) and Paxil® (reference) administered as 1 x 40 mg film-coated tablet under fed conditions.
- Trial name
- NCT00841659
- Testing
- Paroxetine HCl, Paxil®
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate…
- Trial name
- NCT00829673
- Testing
- Dexmethylphenidate Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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.
Healthy
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.
- Trial name
- NCT02516098
- Testing
- hyoscine butylbromide
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Healthy
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
The primary objective of the study was to assess the bioequivalence between the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair HFA [albuterol sulfate] Inhalation Aerosol…
- Trial name
- NCT05300087
- Testing
- Albuterol Sulfate Inhalation Aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy
Cilostazol 100 mg Tablet Formulations Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36…
- Trial name
- NCT00838630
- Testing
- Cilostazol 100 mg tablets, Pletal® 100 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fed conditions.
- Trial name
- NCT01124175
- Testing
- Losartan, Cozaar®
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate…
- Trial name
- NCT00829712
- Testing
- Dexmethylphenidate Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fexofenadine Hydrochloride 180 mg Tablets Under 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
- NCT00835276
- Testing
- Fexofenadine 180 mg tablets, ALLEGRA® 180 mg tablets
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of lamotrigine 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.
- Trial name
- NCT00835263
- Testing
- Lamotrigine, Lamictal®
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA