Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy Male Subjects
Bioequivalence Study of CJ-30060 in Healthy Male Volunteers
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.
- Trial name
- NCT03639493
- Testing
- Exforge® tab 10/160mg, Crestor® tab 20mg, CJ-30060 10/160/20mg
- Where
- South Korea
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy
A Study to Compare Two Formulations of LY3209590 in Healthy Participants
The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits.
- Trial name
- NCT05914688
- Testing
- LY3209590 (Formulation 1), LY3209590 (Formulation 2)
- Where
- Singapore
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Infective Disorder
Clinical Trial of Comparing DA-2902 and DA-2902-R in Healthy Adult Subjects
This study is to compare pharmacokinetics and safety profiles of DA-2902 and DA-2902-R in healthy adult subjects
- Trial name
- NCT07239453
- Testing
- DA-2902, DA-2902-R
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy
Bioequivalence Study of Nefopam Hydrochloride 30mg Tablets vs Acupan® 30mg Tablets in Healthy Subjects
The purpose of this study is to compare the bioavailability of Nefopam Hydrochloride 30mg Tablets (test product) and Acupan® 30mg Tablets (reference product).
- Trial name
- NCT03311022
- Testing
- Nefopam Hydrochloride 30mg Tablets, Acupan® 30mg Tablets
- Where
- United Kingdom
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Galen Limited
Bioequivalence
A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade
Bioequivalence study between two inhaler products (discus) of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT04124094
- Testing
- Test Product (Fluticasone propionate and salmeterol xinafoate inhalation powder/Respirent Pharmaceuticals), Reference Product (SERETIDE DISKUS® 100/50 inhalation powder/GSK), Activated Charcoal suspension
- Where
- Greece
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants
The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to…
- Trial name
- NCT06475729
- Testing
- Citrate-Free Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 498 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer
The primary objective of this study is to assess the bioequivalence of the test product Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL following intravenous administration to healthy…
- Trial name
- NCT00719459
- Testing
- Iron Sucrose
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Fed Conditions, Healthy Volunteer
A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal
Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers
- Trial name
- NCT07333742
- Testing
- Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LG Chem
Therapeutic Equivalency
Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects
The objective of this study was to compare the rate and extent of absorption of pravastatin sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference Pravachol® 80 mg Tablets under fasting…
- Trial name
- NCT00650221
- Testing
- Pravastatin
- Where
- Canada
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions
This is a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers.
- Trial name
- NCT01146106
- Testing
- Pravastatin Sodium
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence
Bioequivalence Study of Oseltamivir Phosphate and TAMIFLU Under Fed Condition in Healthy Volunteers
This study is to evaluate the bioequivalence of Oseltamivir Phosphate Capsules 75 mg versus TAMIFLU 75 mg capsules administered as 75 mg capsules in healthy volunteers under Fed condition.
- Trial name
- NCT04536415
- Testing
- Oseltamivir Phosphate 75 mg capsules, Tamiflu capsules 75 mg
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Austarpharma, LLC
Healthy
A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 milligram [mg]) with respect to the Tylenol 8 hour (H) extended-release (ER) tablet (acetaminophen 650 mg) in…
- Trial name
- NCT04214691
- Testing
- Acetaminophen
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Janssen Korea, Ltd., Korea
Healthy
Bioequivalence Study Between "DA-5215 Tab" and "DA-5215-R Tab"
An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence between "DA-5215 Tab" and "DA-5215-R Tab" in Healthy Volunteers
- Trial name
- NCT05376085
- Testing
- DA-5215 Tab, DA-5215-R Tab
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy Volunteers
Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.
- Trial name
- NCT01632449
- Testing
- Test product, Reference product
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
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.
Fasting
Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory investigations and assess relative safety and…
- Trial name
- NCT01506076
- Testing
- Levocetirizine DiHCl
- Where
- India
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Type II Diabetes
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.
- Trial name
- NCT05108350
- Testing
- T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR, T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy Subjects
Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Relative to Yasmin®
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
- NCT06233058
- Testing
- Drospirenone+ Ethinyl Estradiol Tablets-Test product, Drospirenone+ Ethinyl Estradiol Tablets-Reference product
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
T2DM (Type 2 Diabetes Mellitus)
Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets
This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test…
- Trial name
- NCT07412015
- Testing
- treatment T (dose 1), treatment T (dose 2), treatment R (dose 1)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
Healthy Adults
Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, crossover, in two periods and in two sequences comparative study, where each participant is randomly assigned to the reference or the test formulation in each period…
- Trial name
- NCT03898193
- Testing
- Montelukast, Singulair
- Where
- Russia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
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