Clinical trials: Bioequivalence
Healthy
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions
Objective: To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administered as a 1X100 mg tablet, under fasted conditions.
- Trial name
- NCT00944242
- Testing
- Sertraline, Sertraline Hydrochloride
- Where
- Canada
- Sponsor
- Torrent Pharmaceuticals Limited
Cystic Fibrosis
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene.
- Trial name
- NCT01288170
- Testing
- Nebcinal Tobi, Tobi Nebcinal
- Where
- 2 sites in France
- Volunteers
- 12 people
- Sponsor
- Erempharma
Bioequivalence
Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Trial name
- NCT06830954
- Testing
- Group A, Reference Group
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Tobacco Dependence
Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum
Bioequivalence between oral nicotine replacement products and Nicorette® gum.
- Trial name
- NCT01113424
- Testing
- Nicotine, Nicorette® (Nicotine Gum)
- Where
- Sweden
- Volunteers
- 88 people
- Sponsor
- McNeil AB
Healthy
A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters of tadalafil administered as an fixed dose combination (FDC) (test) of macitentan/tadalafil (10 milligram [mg]/40 mg) and…
- Trial name
- NCT04235270
- Testing
- FDC of Macitentan and Tadalafil, Macitentan, Tadalafil
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Dyslipidaemia
Bioequivalence Study of Capsule and Tablet Formulations of TA-8995
The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.
- Trial name
- NCT02523391
- Testing
- TA-8995
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Xention Ltd
Drug Use
Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers
The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.
- Trial name
- NCT04982874
- Testing
- Furosemide 40 mg, Lasix® 40 mg Tablet
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT. Kimia Farma (Persero) Tbk
Nasal Congestion
Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)
This study will assess the food-effect bioavailability of an extended release formulation of phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl product.
- Trial name
- NCT01354418
- Testing
- Phenylephrine HCl Extended Release, Phenylephrine HCl Immediate Release
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence Study of Budesonide Rectal Aerosol Foam and Uceris® Rectal Aerosol Foam
To evaluate the bioequivalence between the Test Product Budesonide rectal aerosol foam and Reference Product Uceris® rectal aerosol foam after a single-dose in healthy subjects
- Trial name
- NCT02800824
- Testing
- Budesonide, Uceris
- Volunteers
- healthy volunteers welcome
- Sponsor
- Padagis LLC
Healthy
15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting
This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals…
- Trial name
- NCT00834197
- Testing
- Mirtazapine 15 mg (Orally Disintegrating) Tablets, REMERON SolTab® 15 mg Orally Disintegrating Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Hyperplasia Prostatic
Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State
The purpose of this study is to compare the bioavailability (rate and extent of absorption) of two tansulosine 0,4 mg capsule formulations.
- Trial name
- BET04cap (NCT01338623)
- Testing
- Tansulosine
- Where
- Brazil
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biocinese
Healthy Subjects
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/1000 mg Relative to Originator
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
- NCT06233240
- Testing
- Sitagliptin and Metformin Hydrochloride Tablets Test product, Sitagliptin and Metformin Hydrochloride Tablets Reference product
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Study Of The PF-04958242 Blood Concentrations Of A Capsule Formulation Of PF-04958242 Compared To A Solution Formulation
This study will assess the relative bioavailability of a capsule formulation of PF-04958242, relative to a oral solution formulation of PF-04958242 in healthy adult subjects.
- Trial name
- NCT01646840
- Testing
- PF-04958242 capsule, PF-04958242 oral solution
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mg
The objective of this study was to investigate the bioequivalence of Mylan metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets following a single, oral 100/50 mg (1 x 100/50 mg)…
- Trial name
- NCT00649233
- Testing
- Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg, Lopressor HCT® Tablets 100/50 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults
This study is to assess the bioequivalence of a test formulation of vadadustat (A) compared to a reference formulation of vadadustat (B)
- Trial name
- NCT03639155
- Testing
- vadadustat reference tablets, vadadustat test tablets
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Fed
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fed Conditions
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
- NCT01827878
- Testing
- Lisinopril and Hydrochlorothiazide Tablets (20+25) mg, Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects
The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.
- Trial name
- NCT00602589
- Testing
- Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulations
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
Food Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg
The objective of this study was to investigate the bioequivalence of Mylan's ondansetron orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered…
- Trial name
- NCT00648804
- Testing
- Ondansetron Orally Disintegrating Tablets 8 mg, Zofran ODT® Tablets 8 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test…
- Trial name
- NCT00840216
- Testing
- Clarithromycin ER 500 mg tablets, BIAXIN® XL 500 mg tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Otitis Externa
A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par Pharmaceutical Companies, Inc.) to the already-marketed…
- Trial name
- NCT01910155
- Testing
- Ciprofloxacin/Dexamethasone, Ciprodex (R)
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 455 people
- Sponsor
- Par Pharmaceutical, Inc.