Clinical trials: Therapeutic Equivalency, Healthy
Healthy
A Study of Butamirate Citrate Syrup Versus (vs) Sinecod Syrup (Vanilla) in Adult Healthy Study Volunteers
The purpose of this study is to evaluate bioequivalence with respect to rate and extent of absorption of 2-phenylbuturic acid of the novel medication butamirate citrate syrup 1.5 milligrams per milliliter (mg/mL), and the…
- Trial name
- NCT05182047
- Testing
- Butamirate citrate, Sinecod
- Where
- Russia
- Volunteers
- healthy volunteers welcome
- Sponsor
- McNeil AB
Healthy
Bioequivalence Study of Benazepril HCl / Hydrochlorothiazide 20 mg/ 25 mg Tablets Under Fasting Conditions
The purpose of this study was to determine the bioavailability of benazepril and hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration of single doses to normal healthy fasted subjects.
- Trial name
- NCT00778726
- Testing
- Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Subjects in Fasted and Fed State
The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
- Trial name
- NCT03216278
- Testing
- Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500 mg, Dapagliflozin/metformin XR 10/1000mg
- Where
- Brazil
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Non-fasting Conditions
The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co.
- Trial name
- NCT00864734
- Testing
- Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg, CLUCOVANCE® 5 mg/500 mg Tablets, single dose
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Hypercholesterolemia
Bioequivalence Study Of Pediatric Appropriate Formulation
To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.
- Trial name
- NCT00758004
- Testing
- Atorvastatin, Atorvastatin pediatric appropriate formulation
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Food Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan quinapril hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose under fed conditions.
- Trial name
- NCT00649649
- Testing
- Quinapril Hydrochloride Tablets 40 mg, Accupril® Tablets 40 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
IVIVR Assessing PK Parameters Used to Establish Bioequivalence
The purpose of this study is to determine whether defined and limited changes in in vitro dissolution impact the in vivo pharmacokinetics (PK) and relative bioavailability of allopurinol and the active metabolite oxypurinol.
- Trial name
- NCT02398448
- Testing
- Zyloprim® 300 mg, Allopurinol 300 mg; undergranulated, high hardness condition, Allopurinol 300 mg; alternative condition 2
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
Healthy
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of lamotrigine 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.
- Trial name
- NCT00835263
- Testing
- Lamotrigine, Lamictal®
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Pergoveris FD and Liquid China BE Study
The main purpose of this study is to assess the bioequivalence (BE) of the fixed combination of follitropin alfa and lutropin alfa in Pergoveris freeze-dried (FD) (Test 1) or in Pergoveris Liquid (Test 2) versus the…
- Trial name
- NCT04899193
- Testing
- Pergoveris FD, Pergoveris Liquid, Gonal-f
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Benign Prostatic Hyperplasia
Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc.
- Trial name
- NCT03887858
- Testing
- Harnal-D Tab., Chong Kun Dang Tamsulosin HCl Tab.
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Type 2 Diabetes
A HR20031 BE Study on Healthy Subjects
The purpose of this study is to assess the bioequivalence between HR20031 FDC tablet and co-administration of SHR3824 tablets, SP2086 tablets and metformin XR tablets.
- Trial name
- NCT05682495
- Testing
- ARM A, ARM B, ARM C
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent, Healthy Volunteers
A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male Participants
In this bioequivalence study, healthy male participants took the study treatment finerenone in the form of one and two tablets of different strengths by mouth.
- Trial name
- NCT07116512
- Testing
- Finerenone (BAY94-8862): intervention A, Finerenone (BAY94-8862): intervention B
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bayer
Parkinson
Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14…
- Trial name
- NCT02305277
- Testing
- BIA 9-1067 (clinical micronized, CM), BIA 9-1067 (to-be-marketed, TBM)
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy
Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions
An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc.
- Trial name
- NCT00776139
- Testing
- Cetirizine Hydrochloride 10 mg tablet
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female…
- Trial name
- NCT01020877
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteer
A Study to Assess the Bioequivalence of Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Healthy Chinese Subjects.
To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and co-administration of dapagliflozin and metformin XR tablets.
- Trial name
- NCT04856007
- Testing
- Dapagliflozin/metformin XR FDC 5/500 mg, Dapagliflozin/metformin XR FDC 10/1000 mg, Dapagliflozin 5 mg + Metformin 500 mg XR
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Two Way Bioequivalence Study Under Fed Conditions
The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.
- Trial name
- NCT01217801
- Testing
- Ondansetron (ODFS), Ondansetron (ODT)
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- MonoSol Rx
Healthy
Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 mg
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam Extended-release 3 mg tablets to Pharmacia \& Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered…
- Trial name
- NCT00650299
- Testing
- Alprazolam Extended-release Tablets 3 mg, Xanax XR® Tablets 3 mg
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Study of MK-7240 in Healthy Participants (MK-7240-009)
The goal of this study is to learn what happens to MK-7240 in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of MK-7240 and if people tolerate it.
- Trial name
- NCT07405177
- Testing
- Tulisokibart Form 1, Tulisokibart Form 2
- Where
- 2 sites in Australia
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
ADHD
SPD544 High Strength Bioequivalence Study
The purpose of this study is to assess bioequivalence of 2 capsule strengths.
- Trial name
- NCT01183234
- Testing
- SPD544, Methylphenidate hydrochloride
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Shire
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