Clinical trials: Bioequivalence
Healthy
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in fasted subjects.
- Trial name
- NCT01161966
- Testing
- Zonisamide, Zonegran
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co.
- Trial name
- NCT00865241
- Testing
- Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg, CLUCOVANCE® 5 mg/500 mg Tablets, single dose
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Tobacco Use Disorder
To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 4 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 4mg) in healthy smokers under fasting…
- Trial name
- NCT03543137
- Testing
- Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Attention Deficit Disorder With Hyperactivity
A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels
The purpose of this study is to evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single…
- Trial name
- NCT07253441
- Testing
- CTN XR (TBM), CTN SR, CTN XR (Clin)
- Where
- 2 sites in United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions
To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.
- Trial name
- NCT01122953
- Testing
- Phenytoin, Epamin
- Where
- Mexico
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence Study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited under fed conditions.
- Trial name
- NCT01149980
- Testing
- Citalopram Hydrobromide
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Atenolol 100mg Tablets Under Fasting Conditions
The purpose of this study was to determine the bioequivalence of atenolol formulations after administration of single doses to normal healthy subjects under fasted conditions.
- Trial name
- NCT00775580
- Testing
- Atenolol 100mg Tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Under Fasting Conditions
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fasting conditions.
- Trial name
- NCT00870142
- Testing
- AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose, Norvasc® 10 mg Tablets
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Postmenopausal Osteoporosis, Postmenopause
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™.
- Trial name
- NCT00381251
- Testing
- Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Bioequivalence, Healthy Subjects
Bioequivalence Study of 8 mg Perindopril Tert-butylamine / 2.5 mg Indapamide Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets manufactured by PrJSC…
- Trial name
- NCT05464745
- Testing
- PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets, Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets
- Where
- Jordan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Healthy
Food Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg
The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x 15 mg) dose administration under fed…
- Trial name
- NCT00649675
- Testing
- Meloxicam Tablets 15 mg, Mobic® Tablets 15 mg
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers
Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)
- Trial name
- NCT02273531
- Testing
- Asasantin ER, new formulation, Asasantin ER, present commercial formulation
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Benign Prostatic Hyperplasia
Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers After Meal
This study is an open-label, randomized, fed, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc.
- Trial name
- NCT03887871
- Testing
- Harnal-D Tab., Chong Kun Dang Tamsulosin HCl Tab.
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Cardiovascular Diseases, Acute Coronary Syndrome
Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence
This is a pilot study that was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers.
- Trial name
- NCT05474053
- Testing
- Ticagrelor 90mg (Brilique), Ticagrelor 90mg (Ticaloguard)
- Where
- Egypt
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Cairo University
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
Open-label, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects
This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled…
- Trial name
- NCT02806219
- Testing
- Prefilled syringe (PFS), e-Device
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- UCB BIOSCIENCES, Inc.
HIV Infections
Bioequivalence Study to Compare Dolutegravir 50mg Film-coated Tablets
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Dolutegravir 50mg film-coated tablets (50mg Dolutegravir) versus Tivicay 50mg film-coated tablets (50mg Dolutegravir) in…
- Trial name
- NCT06450275
- Testing
- Dolutegravir 50 MG Film Coated Tablet, Tivicay 50mg, film-coated tablets
- Where
- Jordan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence Study of Risperidone 1.0 mg Tablets of Torrent Pharmaceuticals Limited., India and Risperdal® (Risperidone) 1.0 mg Tablets of Janssen Pharmaceutical Products, LP, USA, in Healthy Human Adult Subjects, Under Fasting Conditions
Objective: To assess the bioequivalence of Risperidone 1.0 mg tablets of Torrent Pharmaceuticals Limited., India and Risperdal® (Risperidone) 1.0 mg tablets of Janssen Pharmaceutical Products, LP, USA, in healthy human adult…
- Trial name
- NCT00939497
- Testing
- Risperidone
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Alzheimer's Disease
A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
The present pharmacokinetic study is designed to compare bioavailability and assess bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both formulations will be tested in fasting healthy volunteers
- Trial name
- NCT00468897
- Testing
- RSG XR
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Major Depressive Disorder
Clinical Study of Generic and Brand Bupropion in Depression
Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.
- Trial name
- BALANCE (NCT02209597)
- Testing
- Bupropion XL 300
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Washington University School of Medicine