Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company)…
- Trial name
- NCT00835081
- Testing
- Cefadroxil 500 mg Capsules, DURICEF® capsules 500 mg
- Where
- 2 sites in United States, Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence
Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg
The primary aim of this study is to demonstrate bioequivalence in the rate and extent of absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of 1600 μg, twice a day (b.i.d.) and 1600 μg…
- Trial name
- NCT02206295
- Testing
- selexipag
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Actelion
Healthy
A Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair 10mg Tabs (Merck)
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Montelukast fromAsmakast10 mg tablets (Man.
- Trial name
- NCT02480049
- Testing
- Asmakast, Singulair
- Where
- Egypt
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.
- Trial name
- NCT02596100
- Testing
- Betrixaban
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Healthy
Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fed Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01749228
- Testing
- Etodolac Capsules USP 300 mg, Etodolac
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Diabetes
Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.
- Trial name
- NCT00772265
- Testing
- Wosulin N, Novolin N
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy Subjects
Ticagrelor Tablets 90 mg Relative to Originator Ticagrelor Tablets 90 mg
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- TIC-025-23 (NCT06233266)
- Testing
- Ticagrelor-Test product, Ticagrelor-Reference product
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Hypertension, Hyperlipidemia
Bioequivalence Study of CJ-30061 in Healthy Male Volunteers
To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers
- Trial name
- NCT03657472
- Testing
- CJ-30061, Exforge® 5/160mg & Lipitor® 20mg
- Where
- South Korea
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Relative Bioequivalence
An Open-label Study in Healthy Adults to Evaluate the Relative Bioequivalence of a Single-dose Administration of Sonelokimab Either by a Prefilled Syringe or an Autoinjector
This is a study to confirm the relative bioequivalence of sonelokimab administered subcutaneously via a prefilled syringe (PFS) or an autoinjector (AI) in healthy adult volunteers
- Trial name
- NCT06994936
- Testing
- Sonelokimab
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- MoonLake Immunotherapeutics AG
Healthy Volunteer, Dabigatran
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of…
- Conditions
- Healthy Volunteer, Dabigatran, Bioequivalence Study
- Trial name
- NCT06441916
- Testing
- Dabigatran Etexilate Capsules 150 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy
Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition
This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01504516
- Testing
- Donepezil Hydrochloride, Aricept
- Where
- India
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions
A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.
- Trial name
- NCT02041273
- Testing
- palbociclib isethionate (phase 1 and 2 studies), palbociclib commercial free base capsule
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of Daclatasvir From Prodactariv 60 mg Film Coated Tablets (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Prodactariv 60 mg F.C.T (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and…
- Trial name
- NCT02780362
- Testing
- Prodactariv, Clatazev
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions
The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8 mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy Pharmaceuticals, USA) with Zofran ODT® 8 mg orally…
- Trial name
- NCT01523119
- Testing
- Ondansetron
- Where
- India
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fed Conditions
The objective of this study was to compare the single-dose oral bioavailability of Carvedilol 12.5 mg tablets of Ranbaxy Laboratories with Coreg 12.5 mg tablets of Glaxosmithkline in healthy, adult, human subjects under fed…
- Trial name
- NCT00775619
- Testing
- Carvedilol 12.5 mg tablets
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
Some women cannot have children because they cannot produce enough follicle stimulating hormone (FSH) and luteinising hormone (LH).
- Trial name
- NCT02317809
- Testing
- Liquid pergoveris, Freeze-dried pergoveris
- Where
- Germany
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Parkinson Disease
Relative Bioavailability and Bioequivalence of Opicapone
the purpose assess the relative bioavailability and bioequivalence of two active pharmaceutical ingredient (API) sources of opicapone (OPC, Ongentys® and BIA 9-1067) following single 50 mg dose administration under fasting…
- Trial name
- NCT03820037
- Testing
- Ongentys, BIA 9-1067 (test)
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
Study Design : A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study Primary Objective: To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus…
- Trial name
- NCT01197001
- Testing
- Amlodipine plus Losartan, Amlodipine, Losartan
- Where
- Czechia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Hyperprolactinemia
A Study on Bioequivalence of Cabergoline Tablets in Human Body
The purpose of this study is to evaluate the bioequivalence of the test formulation and reference formulation of cabergoline tablets in healthy Chinese subjects under fasting and postprandial conditions.
- Trial name
- NCT07008417
- Testing
- Cabergoline tablets test formulation, Cabergoline tablets reference formulation
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Healthy
Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg
The present study was conducted to find out whether the bioavailability of 0.25 mg pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was equivalent to the reference drug (Sifrol® tablet 0.25 mg…
- Trial name
- NCT02660060
- Testing
- Pramipexole Dexa Medica, Pramipexole Boehringer Ingelheim Pharma
- Where
- Indonesia
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
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