Clinical trials: Bioequivalence Study in Healthy Subjects
Anxiety Disorders
Bioequivalence Trial of Alprazolam 0.5 mg Tablets
The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. Test product was Zamoprax® 0.5 mg (GlaxoSmithKline) and reference product Tafil® 0.5 mg (Pharmacia \& Upjohn).
- Trial name
- NCT01745562
- Testing
- Alprazolam 0.5 mg
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose…
- Trial name
- NCT00649974
- Testing
- Valacyclovir Hydrochloride Tablets 1000 mg, Valtrex® Tablets 1000 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence
Diflucan Bioequivalence Study For Transferring The Manufacture
This study is to assess the bioequivalence between fluconazole 50mg capsules from two different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period crossover study in healthy Korean male and female…
- Trial name
- NCT03821480
- Testing
- Test drug, Reference drug
- Where
- South Korea
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Bioequivalence
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
- NCT03820180
- Testing
- Test Product, Reference Product
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Fasting
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fasting conditions.
- Trial name
- NCT01286688
- Testing
- Terbinafine Hydrochloride Tablets, 250 mg
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.
- Trial name
- NCT00648388
- Testing
- Cilostazol Tablets 100 mg, Pletal® Tablets 100 mg
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Food Study Metformin Hydrochloride ER Tablets 750 mg and Glucophage XR 750 mg
The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 750 mg (1 x 750 mg) dose administered under…
- Trial name
- NCT00649350
- Testing
- Metformin Hydrochloride ER Tablets 750 mg, Glucophage XR 750 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Fasting
Bioequivalence Study of Olanzapine Tablets, 5 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fasting conditions and to monitor the…
- Trial name
- NCT01503398
- Testing
- Olanzapine
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Under Fasting Conditions
The purpose of this bioequivalence study is to compare the test Tizanidine Hydrochloride 4mg tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in healthy adult subjects under fasting…
- Trial name
- NCT01146028
- Testing
- Tizanidine
- Where
- Canada
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the…
- Trial name
- NCT01220219
- Testing
- Pregabalin controlled release, 82.5 mg, Pregabalin controlled release, 165 mg, Pregabalin immediate release, 75mg
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Subjects
PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers
A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults
- Trial name
- NCT07256600
- Testing
- DWJ1445, DWC202506
- Where
- South Korea
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate…
- Trial name
- NCT00829712
- Testing
- Dexmethylphenidate Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one…
- Trial name
- NCT00649467
- Testing
- Topiramate Sprinkle Capsules 25 mg, Topamax® Sprinkle Capsules 25 mg
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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
Bioequivalence Study in Healthy Subjects
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 850 mg Tablets Under Fed Conditions.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL24-PC019 (NCT07633028)
- Testing
- Empagliflozin/metformin 12.5/850 mg tablet (test), Synjardy 12.5/850 mg tablet (Reference)
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- ADIUM
Healthy
Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mg
"The objective of this study was to investigate the bioequivalence of Mylan cetirizine HCl 10 mg tablets to Pfizer's Zyrtec® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.
- Trial name
- NCT00650065
- Testing
- Cetirizine HCl Tablets 10 mg, Zyrtec® Tablets 10 mg
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Acute Lymphoblastic Leukemia
Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
The objective of this study was to assess the bioequivalence of a potential generic 6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol® (mercaptopurine) 50-mg scored tablets following a single 50…
- Trial name
- NCT00602134
- Testing
- 6-Mercaptopurine
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bioequivalence
Bioequivalence of Amphotericin B Liposome for Injection
The main purpose of this study is to evaluate the bioequivalence of two different amphotericin B liposome for injection after single IV infusion at the same dose in normal healthy subjects.
- Trial name
- NCT05913921
- Testing
- Amphotericin B liposome for injection, AmBisome
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Pulmonary Arterial Hypertension (PAH)
Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag)
Randomized, single oral dose, two-period, two-treatment, two-sequence open-label, crossover, bioequivalence study to compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) versus Uptravi® 400mcg Film Coated Tablets (400…
- Trial name
- NCT06932198
- Testing
- Selexipag Film Coated Tablets, Uptravi® Film Coated Tablets
- Where
- Jordan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
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