Clinical trials: Therapeutic Equivalency, Healthy
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
Pain
Study to Test the Blood to See if a New Medicine is Likely to Provide Pain Relief Similar to a Product Already Sold in Stores
This study is designed to assess bioequivalence between one test and one reference formulation used for temporary relief of pain.
- Trial name
- NCT01555476
- Testing
- Ibuprofen
- Where
- Sweden
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Bioequivalency
Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.
The present study was designed to assess the bioequivalence and pharmacokinetic profiling of a brand generic formulation of darifenacin [Darisec(R)]vs. the innovator [Enablex(R)]in healthy volunteers after a high fat breakfast.
- Trial name
- NCT01227811
- Testing
- Darifenacin
- Where
- Uruguay
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Center for Clinical Pharmacology Research Bdbeq S.A.
Healthy
Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations
Generic medications should be the equivalent of brand medications with the exception of their price. Before a generic medication is introduced, its bioequivalence within a window of 80 to 125% of the original has to be…
- Trial name
- NCT00676039
- Testing
- Venlafaxine, Gen-Citalopram, Effexor XR
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Ottawa
Healthy
Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers
Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277 capsule
- Trial name
- NCT02262559
- Testing
- BIBR 277 tablet, BIBR 277 capsule
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Study Participants
A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants
The purpose of the study is to compare the pharmacokinetics (PK) of bimekizumab when administered subcutaneously (sc) as 1x2 mL versus 2x1 mL, using a bimekizumab-safety syringe presentation or bimekizumab-auto-injector…
- Trial name
- NCT04255862
- Testing
- Bimekizumab
- Where
- Germany
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Healthy
Bioequivalence of 5 Tablets of 100 mg Versus 2 Tablets of 250 mg TF3 of Tepotinib
This study investigated the bioequivalence of the 100 milligrams (mg) and 250 mg dose strengths of tepotinib tablet formulation 3 (TF3) when administered at the same dose under fasted condition.
- Trial name
- NCT04204902
- Testing
- Tepotinib 100 mg, Tepotinib 250 mg
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Allergic Asthma
A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers
This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and…
- Trial name
- NCT06494345
- Testing
- Genolair, solution for subcutaneous administration, 150 mg, Genolair, lyophilisate for the preparation of solution for subcutaneous administration, Xolair®, solution for subcutaneous administration, 150 mg
- Where
- Russia
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Fed
Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01744873
- Testing
- Bisoprolol Fumarate Tablet 10 mg, Bisoprolol
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Hypercholesterolaemia, Mixed Dyslipidaemia
Single Dose Oral Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets in Healthy Adult Human Subjects Under Fasting Conditions.
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
- Conditions
- Hypercholesterolaemia, Mixed Dyslipidaemia, Cardiovascular Diseases
- Trial name
- NCT06923956
- Testing
- Bempedoic Acid Film Coated Tablet, Nilemdo® (Bempedoic Acid) Film-coated tablets
- Where
- India
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Bioequivalence, Diabetes Mellitus, Type 2
Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Tablets in Healthy Male and Female Volunteers
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of metformin/sitagliptin after a single oral dose administration under fed…
- Trial name
- NCT05549570
- Testing
- Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Healthy
A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women
The main objectives of this study are to determine the bioequivalence of the hormones (example, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch using the newly sourced adhesive component…
- Trial name
- NCT04017195
- Testing
- EVRA patch (NGMN+EE) (Treatment A) (Reference), High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
- Where
- 3 sites in Belgium, Germany and 1 more
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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
Infections, Respiratory Tract
A Bioequivalence Study of an Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil 2% Oral Solution
This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover design study in adult male and female healthy participants.
- Trial name
- NCT02688361
- Testing
- Fluimucil® 2% solution, Acetylcysteine 2% solution
- Where
- Germany
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence
Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects
Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer® Actelion)
- Trial name
- NCT04101370
- Testing
- Bosentan 125 mg, Tracleer 125Mg Tablet
- Where
- Russia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Geropharm
Bronchial Asthma, Perennial Allergic Rhinitis
Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers
To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.
- Trial name
- NCT07231861
- Testing
- AJU-R713, R713R
- Where
- South Korea
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- AJU Pharm Co., Ltd.
Healthy
Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch
This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy (i.e., estrogen for surgically postmenopausal…
- Trial name
- NCT00791856
- Testing
- testosterone
- Where
- 4 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Warner Chilcott
Healthy
Food Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under…
- Trial name
- NCT00649259
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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.
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