Clinical trials: Therapeutic Equivalency
Healthy
Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions
Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets aventis Administered as 1 x 180 mg Tablet in Healthy Subjects under…
- Trial name
- NCT01066767
- Testing
- Fexofenadine
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Subjects
Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Relative to Yaz®
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
- NCT06233071
- Testing
- Drospirenone+ Ethinyl Estradiol Tablets-Test product, Drospirenone+ Ethinyl Estradiol Tablets-Reference product
- Where
- Thailand
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Hypertension, Essential
Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed
Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed…
- Trial name
- NCT01350609
- Testing
- Nifedipine/Candesartan (BAY 98-7106), Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
- Where
- Germany
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence Study of Gabapentin 800 mg Tablets Under Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals…
- Trial name
- NCT00778401
- Testing
- Gabapentin tablets 800 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bioequivalence
Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product
This Pilot study investigated the bioavailability in adult human subjects of 1 tablet formulations containing Diosmin/Hesperidin (90/10) 500 mg. The Pilot study was performed at a single site with 12 subjects.
- Trial name
- NCT05158192
- Testing
- Diosmin/Hesperidin (90/10) 500 mg Test Drug, Diosmin/Hesperidin (90/10) 500 mg Reference Product
- Where
- India
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
Healthy
Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fed Conditions
Objective: to compare the single dose bioavailability of Torrent's Losartan Potassium and Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck \& Co., Inc.
- Trial name
- NCT01218724
- Testing
- Losartan Potassium and Hydrochlorothiazide Tablets
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Hypertension
Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)
The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male volunteers.
- Trial name
- NCT02988362
- Testing
- HL068 16/10mg, Candesartan 16mg and Amlodipine 10mg
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- HanAll BioPharma Co., Ltd.
Hyperphosphatemia
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.
- Trial name
- NCT00742820
- Testing
- Calcium Acetate Oral Solution 667 mg per 5 mL, Calcium Acetate 667 mg GelCaps, Calcium Citrate 950 mg Caplets
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Fresenius Medical Care North America
Healthy
Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcg
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 mcg tablets to Abbott's Synthroid® 300 mcg tablets following a single, oral 600 mcg dose (2 × 300 mcg) administered under…
- Trial name
- NCT00648882
- Testing
- LEVOTHYROXINE SODIUM TABLETS,, SYNTHROID® 300 mcg Tablets
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers
This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.
- Trial name
- NCT06010589
- Testing
- DWJ1558, DWC202310 and DWC202311
- Where
- South Korea
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy
Food Study of Doxycycline Monohydrate Tablets 100 mg and Adoxa Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's doxycycline monohydrate 100 mg tablets to Par's Adoxa® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fed…
- Trial name
- NCT00648180
- Testing
- Doxycycline Monohydrate Tablets 100 mg, Adoxa Tablets 100 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence, AUC, Cmax, Pharmacokinetics
Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co.
- Trial name
- NCT03121820
- Testing
- Memantinol tablets, 20 mg, Akatinol Memantine® tablets, 20 mg
- Where
- Russia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Geropharm
Healthy
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA with that of 3 mg XANAX XR® Tablets by…
- Trial name
- NCT00830024
- Testing
- Alprazolam Extended-Release 3 mg Tablets
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal…
- Trial name
- NCT01291524
- Testing
- Pregabalin controlled release, 330 mg, 400 to 500 calorie, Pregabalin controlled release, 330 mg, 600- 750 calorie, Pregabalin controlled release, 330 mg, bedtime
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence Study of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100…
- Trial name
- NCT04494191
- Testing
- Flibanserin 100Mg Tab, Flibanserin 100 MG [Addyi]
- Where
- Egypt
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Fed Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg
The objective of this study was to investigate the bioequivalence of Mylan's nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose…
- Trial name
- NCT00648297
- Testing
- Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg, Corzide® Tablets 80 mg/5 mg
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Asthma
A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma
Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg and…
- Trial name
- NCT03676413
- Testing
- Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals, ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
- Where
- Greece
- Volunteers
- 451 people
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Hypertension
A Bioequivalence Study Between Telmione Plus 80/12.5mg and Micardis Plus 80/12.5 mg in Healthy Adult Volunteers
To compare the pharmacokinetics and safety after a single dose administration of Telmione plus® 80/12.5mg and Micardis plus® 80/12.5mg in healthy adult volunteers
- Trial name
- NCT05040880
- Testing
- Telmione plus 80/12.5mg, Micardis plus 80/12.5mg
- Where
- South Korea
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Bioequivalence, Asthma
A Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT04746040
- Testing
- Test, Reference
- Where
- Greece
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x…
- Trial name
- NCT01019590
- Testing
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg, Benicar HCT ® Tablets 40 mg/25 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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