Clinical trials: Therapeutic Equivalency, Healthy
Pharmacology, Clinical
Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations
Primary Objective: To compare the bioavailability of a single dose of fluconazole 150 mg capsules (Test product) with the bioavailability of a single dose of Diflucan™ capsules, 150 mg (Reference) administered under fasting…
- Trial name
- Orca (NCT03929861)
- Testing
- Fluconazole (BAYT006267) 150 mg capsules, Fluconazole 150 mg capsules (DiflucanTM)
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
HIV, AIDS
Bioequivalence Study of Pediatric Formulations to Treat HIV Infection
The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in comparison to an innovator product.
- Trial name
- NCT01469520
- Testing
- Epivir®, Retrovir® and Viramune®, Lamivudine, Zidovudine and nevirapine, Lamivudine, zidovudine, nevirapine
- Where
- Nigeria
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Elim Pediatric Pharmaceuticals Inc.
Healthy Volunteers
A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants
The purpose of this study is to assess the relative bioavailability and bioequivalence of 2 strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and pioglitazone tablets in healthy Russian…
- Trial name
- NCT03501277
- Testing
- Alogliptin, Pioglitazone, SYR-322-4833 BL
- Where
- Russia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Glimepiride 4 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of glimepiride 4 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00835172
- Testing
- Glimepiride 4 mg Tablets, AMARYL® 4 mg Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Phase 1, Bioequivalence
Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects
This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate Altebrel relative to etanercept reference product (Enbrel®) and evaluate safety and tolerability of Altebrel, in a crossover fashion in…
- Trial name
- NCT03273088
- Testing
- Etanercept
- Where
- Iran
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- AryoGen Pharmed Co.
Pharmacokinetics
A Single Dose, Cross-over Bioequivence Study Comparing Galantamine IR (Immediate Release) Table and Galantmine OS (Oral Solution) in Healthy Volunteers
The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet.
- Trial name
- NCT00645554
- Testing
- Galantamine oral solution
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Erectile Dysfunction
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
- Trial name
- NCT01254383
- Testing
- Sildenafil Tablet, Sildenafil ODT
- Where
- Singapore
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence of Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional Telmisartan Tablet in Healthy Male Volunteers
Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two tablets of the telmisartan 40 mg conventional tablet
- Trial name
- NCT02261129
- Testing
- Telmisartan film-coated tablet, Telmisartan uncoated tablet
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects
Lysergic acid diethylamide (LSD) is used as recreational substance and as a research substance to study the mind. Recreationally, LSD is typically used in the form of "blotters" containing LSD tartrate.
- Trial name
- LSD-Bio (NCT04865653)
- Testing
- Lysergic Acid Diethylamide Base oral drinking solution, Lysergic Acid Diethylamide Base solid orodispersible film, Lysergic Acid Diethylamide Tartrate oral drinking solution
- Where
- Switzerland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Healthy
Bioequivalence Study of Ramipril 10 mg Capsules Under Fed Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules of Ohm Laboratories Inc., with Altace®…
- Trial name
- NCT00879788
- Testing
- Ramipril 10mg capsules
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed Conditions
The objective of this study was to compare and evaluate the single-dose oral bioavailability of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr.
- Trial name
- NCT01267383
- Testing
- Sertraline
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Pain
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants.
- Trial name
- NCT05737069
- Testing
- Ibuprofen arginine granules 400 mg, Ibuprofen arginine granules 400 mg (Spedifen)
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- HALEON
Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch
Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch
STUDY TITLE: A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy…
- Trial name
- NCT02727205
- Testing
- Rotigotine Transdermal System
- Where
- 2 sites in United States, Canada
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Inflamax Research Incorporated
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.
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 Participants
Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects
This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days.
- Trial name
- NCT06360445
- Testing
- Olaparib Tablet test formulation 100mg, Olaparib Tablet reference formulation 100mg, Olaparib Tablet test formulation 150mg
- Where
- China
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
Healthy
A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets
A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg…
- Trial name
- NCT01322867
- Testing
- alprazolam tablet, alprazolam oral solution
- Where
- Brazil
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Evaluating the Bioequivalence of HIP1403, HGP0919
The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 in healthy male volunteers
- Trial name
- NCT02473900
- Testing
- HIP1403, HGP0919
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
To Determine Bioequivalence Under Fed Conditions
The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co.
- Trial name
- NCT05329857
- Testing
- Metformin and Vildagliptin 1000/50 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AET Laboratories Private Limited
Human Immunodeficiency Virus (HIV) Infection
Bioequivalence Study of ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions
This clinical trial aims to evaluate the bioequivalence of a single oral dose of the test drug ADC118 tablets compared with the reference drugs (ACC017 tablets and emtricitabine/tenofovir alafenamide fumarate tablets [II]) under…
- Trial name
- NCT07753902
- Testing
- ACC118-Test, Reference
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
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