Clinical trials: Therapeutic Equivalency, Healthy
Bioequivalence
A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 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
- NCT04564456
- Testing
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent, ADVAIR DISKUS® 500/50
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
Bioequivalence Study of Bilastine Tablets in Healthy Chinese Subjects
Using a single-center, open, randomized, single-dose, double-cycle, double-crossover trial design method (washout period of 7 days), 40 screened and qualified healthy subjects were randomly divided into 2 groups, the T-R group…
- Trial name
- NCT06098261
- Testing
- Test (T) Bilastine, Reference (R) Bilastine
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Fed
Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01578265
- Testing
- Ondansetron Tablets USP 8 mg, Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.
- Trial name
- NCT02596100
- Testing
- Betrixaban
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Healthy
A Relative Bioavailability Study of Griseofulvin 125 mg/5 mL Suspension Under Fasting Conditions
To compare the rate and extent of absorption of griseofulvin from a test formulation of Griseofulvin 125 mg/5 mL Suspension versus the reference Grifulvin V® 125 mg/5 mL Suspension under fasting conditions.
- Trial name
- NCT00864071
- Testing
- Griseofulvin 125 mg/5 mL Suspension, single dose, Grifulvin V® 125 mg/5 mL Suspension, single dose
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Intermittent Claudication
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of…
- Trial name
- NCT05466734
- Testing
- Cilostazol Tablet 100 mg, PMR Tablet 135 mg
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Genovate Biotechnology Co., Ltd.,
Healthy
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fed conditions.
- Trial name
- NCT00870571
- Testing
- AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose, NorvasC® 10 mg Tablets
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Fasting 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
- NCT01020214
- 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
Healthy
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.
- Trial name
- NCT00648219
- Testing
- Olmesartan Medoxomil Tablets 40 mg, Benicar® Tablets 40 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalency
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions
Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fed conditions.
- Trial name
- NCT00803764
- Testing
- Naproxen Tablets, 500 mg
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Perrigo Company
Healthy
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
- Trial name
- NCT02129192
- Testing
- Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet, T80/A5/H12.5 mg FDC tablet
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Bioequivalence Study of Prednisolone and Dexamethasone
The purpose of this study is to compare two different glucocorticoids, prednisolone and dexamethasone at two different doses for their organ specific effects, utilizing modern day standards.
- Trial name
- CORE (NCT04733144)
- Testing
- Prednisolone, Dexamethasone
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Healthy
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed Conditions
This is a single Dose Two-Way Crossover Fed Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy Volunteers.
- Trial name
- NCT01146093
- Testing
- Pravastatin Sodium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Menopause
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women
The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new…
- Trial name
- NCT00396799
- Testing
- bazedoxifene/conjugated estrogens
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hypertension
Baxdrostat Bioavailability and Bioequivalence Study
The goal of this study was to compare the characteristics of a new tablet formulation versus an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood and to compare the effect of food on these…
- Trial name
- NCT05963009
- Testing
- baxdrostat (formerly CIN-107) oral solution
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Nirmatrelvir & Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg Film Coated Tablets (Pfizer Europe, Belgium)
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Nirmatrelvir \& Ritonavir From Copaxid 150 +100 mg Tablets (Eva…
- Trial name
- NCT05491330
- Testing
- Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose), Nirmatrelvir 150 mg + Ritonavir 100 mg (test), Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)
- Where
- Egypt
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg
The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg (1 x 40 mg) dose administration under fasting…
- Trial name
- NCT00649636
- Testing
- Fluoxetine Capsules 40 mg, Prozac Pulvules 40 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.
Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way…
- Trial name
- NCT03317236
- Testing
- Quetiapine
- Where
- Argentina
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorio Elea Phoenix S.A.
Healthy
Bioequivalence Study of Ibuprofen 400 mg/10 mL Oral Suspension vs. MOMENTACT 400 mg Film-coated Tablet
The main objective of the study is to evaluate the bioequivalence of a new formulation of ibuprofen 400 mg/10 mL oral suspension vs.
- Trial name
- NCT02902302
- Testing
- Ibuprofen 400 mg/10 mL oral suspension, MOMENT 400 mg coated tablet
- Where
- Switzerland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Healthy Volunteer
The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions
- Trial name
- NCT06244407
- Testing
- Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Bio service
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