Clinical trials: Therapeutic Equivalency, Healthy
Hypertension
Bioequivalence Study in Healthy Subjects
This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1…
- Trial name
- NCT00844324
- Testing
- Candesartan cilexetil
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
Zoliflodacin Bioequivalence and Drug-Drug Interaction Study
this study will be a Phase 1, single-dose, two parallel cohorts, open-label, randomized study in healthy subjects with Cohort 1 as bioequivalence (BE) and food effect study and Cohort 2 as a drug-drug interaction (DDI) study.
- Trial name
- NCT05635305
- Testing
- Zoliflodacin Patheon
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Global Antibiotics Research and Development Partnership
Healthy
A Bioequivalence Study Of Ibuprofen 50mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form.
An open label, randomized, 2x2 crossover, single dose, phase 4 study to determine the pharmaceutical bioequivalence of ibuprofen 50mg/ml (laboratórios pfizer ltda) oral suspension versus alivium ® 50mg/ml (mantecorp indústria…
- Trial name
- B4371004 (NCT01350596)
- Testing
- Alivium®, Ibuprofen
- Where
- Brazil
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets
The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.
- Trial name
- NCT01672788
- Testing
- Empagliflozin, Empagliflozin + Metformin, Metformin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Valsartan 320mg Tablets Under Fed Conditions
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence, single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg under fed conditions.
- Trial name
- NCT02197494
- Testing
- Valsartan
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
PAH
Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fed conditions.
- Trial name
- NCT06553937
- Testing
- Macitentan and Tadalafil, PrOpsynvi® Film-Coated Tablets
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy Volunteers, Bioequivalence Study
Bioequivalence Study of Neurogabin-M (Gabapentin 400 mg) Capsule With Parketin (Gabapentin 400 mg) Capsules
This is a single-dose, two-periods, two-sequence, two-way crossover, single oral dose bioequivalence study.
- Trial name
- BE (NCT05436886)
- Testing
- Neurogabin (Gabapentin) 400 mg capsule, Parketin (Gabapentin) 400 mg capsule
- Where
- Pakistan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Karachi
Healthy
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay
The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following…
- Trial name
- NCT00647686
- Testing
- Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay, Fentanyl Transdermal System 25 mcg/h
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir
Bioequivalence study of two formulations containing a fixed dose combination of 600 mg Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets under a single-dose, two-way crossover design.
- Trial name
- NCT03309566
- Testing
- Efavirenz, tenofovir disoproxil fumarate and emtricitabine
- Where
- Argentina
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorio Elea Phoenix S.A.
Healthy
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and low dose empagliflozin/500 mg metformin [Test 2])…
- Trial name
- NCT01844531
- Testing
- empagliflozin, metformin (Glucophage®), empagliflozin and metformin
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivaelnce Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fed Conditions
To compare the single-dose oral bioavailability of clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin 250 mg/5 mL granules for oral suspension in healthy, adult, human, male subjects under…
- Trial name
- NCT00775372
- Testing
- Clarithromycin 250mg/5mL
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteers
Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers
An open, randomized, single-dose, three-cycle, three-sequence crossover study was conducted in 36 healthy volunteers under fasting condition to evaluate the bioequivalence of two abiratone acetate tablets.
- Trial name
- NCT04863105
- Testing
- Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
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 Volunteer, Healthy Adult Participants
A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each.
- Trial name
- NCT07782775
- Testing
- Efgartigimod PH20 SC via PFS, Efgartigimod PH20 SC via AI
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- argenx
Random Allocation, Intermittent Fasting
Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers
This single-dose, open-label, randomized, four-way crossover study evaluates the pharmacokinetics, safety, and tolerability of TAH3311 5 mg in healthy volunteers under fasted and fed conditions.
- Conditions
- Random Allocation, Intermittent Fasting, Enteral Feeding
- Trial name
- NCT06689436
- Testing
- 5 mg Apixaban Oral Dissolving Film (fasting), 5 mg Apixaban Oral Dissolving Film (fed), 5 mg Apixaban Oral Tablet (US RS/RLD)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- TAHO Pharmaceuticals Ltd.
Healthy
A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg venlafaxine (as venlafaxine hydrochloride)…
- Trial name
- NCT00871364
- Testing
- VENLAFAXINE TABLETS 50 mg , single dose, Effexor® Tablets equivalent to 50 mg venlafaxine
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy Postmenopausal Females
Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)
For the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (NOMAC) with estradiol (E2).
- Trial name
- NCT01345786
- Testing
- Commercial NOMAC-E2, Phase 3 NOMAC-E2 "Batch A", Phase 3 NOMAC-E2 "Batch B"
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Healthy
A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the safety and pharmacokinetics after co-administration of CTL0201 and CTL0202 or administration of CT-L02 in healthy volunteers.
- Trial name
- NCT07128654
- Testing
- CTL02, CTL0201, CTL0202
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy
Fed Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GSK's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administration under…
- Trial name
- NCT00650494
- Testing
- Valacyclovir Hydrochloride Tablets 1000mg, Valtrex® 1000 mg
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Granisetron 1 mg Tablets, Non-fasting
The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects…
- Trial name
- NCT00834522
- Testing
- Granisetron hydrochloride 1 mg tablets, Kytril® 1 mg tablets
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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