Clinical trials: Therapeutic Equivalency, Healthy
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.
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
- Trial name
- NCT00652730
- Testing
- Buspirone HCl, Buspar
- Where
- Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions
The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fed…
- Trial name
- NCT01131767
- Testing
- Naproxen Sodium & Pseudoephedrine HCl
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Peptic Ulcer Disease
Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately
The purpose of this study is to investigate whether treatment with a combination capsule of Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within the body) as these medications taken…
- Trial name
- NCT00998075
- Testing
- Esomeprazole/ASA Fixed Combination, Esomeprazole - Nexium, ASA
- Where
- Canada
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Urologic Diseases
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
The purpose of this study is to assess the bioequivalence of the second generation dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available commercial combination of dutasteride 0.5 milligram…
- Trial name
- NCT02052713
- Testing
- Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg, Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Fosinopril Sodium / Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fed Conditions
The objective of this study is to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited with that of Monopril ® - HCT 20-12.5 mg tablets by Bristol…
- Trial name
- NCT00778713
- Testing
- Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects
The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.
- Trial name
- NCT00602589
- Testing
- Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulations
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Schizophrenia
A Bioequivalence Study of 15 mg ER OROS Paliperidone
The purpose of this study is to evaluate the bioequivalence between the Phase 3 and the to-be-marketed formulations of extended release (ER) OROS paliperidone and to evaluate the effect of food on the highest to be marketed…
- Trial name
- NCT00892489
- Testing
- ER OROS Paliperidone
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers
The study investigated the bioequivalence between the new and the approved formulation for levothyroxine.
- Trial name
- NCT03979274
- Testing
- Reference Eutirox®, Test Eutirox®
- Where
- Mexico
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Solid Tumor
Bioequivalence Study of Famitinib Malate in Healthy Volunteers Under Fasting Condition
The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 28 healthy subjects. Subjects will receive famitinib malate on Day1 and Day13.
- Trial name
- NCT05336279
- Testing
- famitinib malate T(5 mg*4)、famitinib malate R(20 mg)
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.
- Trial name
- NCT01645423
- Testing
- Atorvastatin Calcium Tablets, 80 mg
- Where
- India
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Leflunomide 20 mg Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc.
- Trial name
- NCT00834418
- Testing
- Leflunomide 20 mg Tablets, ARAVA™ 20 mg Tablets
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence, Adhesion
Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects
This study was intended to demonstrate bioequivalence of the Amarin's Rotigotine patch respect to Neupro, (RLD), as well as non-inferiority in adhesion, when tested at a dose of 2 mg/24h in healthy subjects of both sexes.
- Conditions
- Bioequivalence, Adhesion, Adverse Effects
- Trial name
- No acronyms (NCT07769359)
- Testing
- Rotigotine Transdermal Delivery System (TDS)
- Where
- India
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Amarin Technologies S.A.U.
Infection, Human Immunodeficiency Virus
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects.
- Trial name
- NCT03078556
- Testing
- Dolutegravir, Lamivudine, Dolutegravir + Lamivudine FDC Formulation 1
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Cardiomyopathy
A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
- Trial name
- NCT07479641
- Testing
- Test formulation of HRS-1893 tablet, Reference formulation of HRS-1893 tablet
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy Subjects
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
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
- NCT06233227
- Testing
- Dutasteride-Test product, Dutasteride-Reference product
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Fed Study of Oxybutynin Chloride Extended-release 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
- NCT00649727
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Chronic Hepatitis b
Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers
A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with reference formulation entecavir tablets (Baraclude®)…
- Trial name
- NCT03847246
- Testing
- Baraclude® tablets,1.0 mg, Entecavir tablets,1.0 mg
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Psoriasis
Bioequivalence Test of Hemay005 Tablets
The pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations.
- Trial name
- NCT06610903
- Testing
- Hemay005
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
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