Clinical trials: To Determine Bioequivalence Under Fasting Conditions
Healthy
Study to Determine the Equivalence of Two Products Containing Metronidazole Benzoate
The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated…
- Trial name
- NCT02402283
- Testing
- Metronidazole benzoate oral granules, Flagyl 400 mg Tablets
- Where
- Jordan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
- Trial name
- NCT00652730
- Testing
- Buspirone HCl, Buspar
- Where
- Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions
To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT
- Trial name
- NCT00654277
- Testing
- Ondansetron, Zofran
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Bioequivalence Study of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland).
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules…
- Trial name
- NCT04657744
- Testing
- Sphingomod, Gilenya
- Where
- Egypt
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Smoking Cessation
Single-Dose Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges
The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy smokers.
- Trial name
- NCT03432273
- Testing
- Nicotine lozenge
- Where
- South Africa
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Fertin Pharma A/S
Cardiovascular Disease
Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects
Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate (ADP)-induced platelet aggregation. This is an open-label, randomized, single dose, three-way cross over, six sequence study to investigate the…
- Trial name
- NCT02502812
- Testing
- Clop F1, Clop F2, Innovator
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Urinary Tract
A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects
This is an open-label, randomized, single dose, two-sequence two-period crossover study, separated by 7 days washout interval from the first Study Drug Administration.
- Trial name
- NCT02446496
- Testing
- Cefadroxil tablets manufactured by GSK, Cefadroxil tablets manufactured by NP
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Ivermectin From Revemact 6 mg Tablets (Man. by EVA Pharma for Horus for Pharmaceutical Industries, Egypt) and Stromectol 2*3 mg Tablets (Merck Sharp & Dohme B.V., Haarlem, The Netherlands)
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Ivermectin from Revemact 6 mg tablets (Man.
- Trial name
- NCT04854460
- Testing
- Revemact, Stromectol (first dose), Stromectol (second dose)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions
Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg ODT
- Trial name
- NCT00659074
- Testing
- Ondansetron, Zofran
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Hypertension
A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323
This study is required to confirm the suitability of a candidate FDC of 16mg candesartan cilexetil/12.5mg HCTZ (GSK587323) formulation for further development and provide data to allow the design of a future pivotal…
- Trial name
- NCT02094924
- Testing
- GSK587323, FDC of candesartan cilexetil 16 mg and HCTZ 12.5mg
- Where
- India
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
- Trial name
- NCT00652704
- Testing
- Doxycycline monohydrate, Monodox
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Propranolol Under Fasting Conditions
To compare the single-dose bioavailability of Propranolol 160 Mg ER capsules with Inderal-La
- Trial name
- NCT00653120
- Testing
- Propranolol, Inderal-LA
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Bioequivalance
Bioequivalence Study of Vortioxetine in 20 mg Coated Tablets in Healthy Subjects Under Fasting Conditions
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL24-PC031 (NCT07624357)
- Testing
- Reference, Test
- Where
- Mexico
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ADIUM
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Clonazepam Tablets Under Fasting Conditions
To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1 mg
- Trial name
- NCT00652639
- Testing
- Clonazepam, Klonopin
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Respiratory Disorders, Asthma and Rhinitis
Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions
This study is conducted to determine whether the test product (GW483100 10 mg containing montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference montelukast sodium 10 mg tablets (innovator…
- Trial name
- NCT02658422
- Testing
- Test Montelukast, Reference Montelukast
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
To Determine Bioequivalence Under Fasting Conditions
Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions
To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
- Trial name
- NCT00652795
- Testing
- Doxycycline Monohydrate, Monodox
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Bioequivalence Study of Favipiravir From Flupirava 200 mg Tablet (European Egyptian Pharmaceutical Industries , Egypt) Versus Avigan 200 mg Tablets (Man. by Toyama Chemical Co., Ltd Japan)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Favipiravir from Flupirava 200 mg tablet (European Egyptian Pharmaceutical Industries, Egypt) versus Avigan 200 mg…
- Trial name
- NCT04478448
- Testing
- Flupirava, Avigan
- Where
- Egypt
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Bacterial Infections
Study to Determine the Equivalence of Three Products Containing Metronidazole Benzoate.
The purpose of this study is to determine whether Terix Labs Ltd Metronidazole benzoate (400 mg Metronidazole Per Sachet Oral Granules) is bioequivalent to 500 mg Sanofi-aventis Flagyl 125 mg/5 ml (125 mg Metronidazole Per 5 ml…
- Trial name
- NCT02146209
- Testing
- Metronidazole benzoate, Flagyl 125 mg/5 ml oral suspension, Flagyl 400 mg Tablets
- Where
- Jordan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
To Determine Bioequivalence Under Fasting Conditions
Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
- Trial name
- NCT00653055
- Testing
- Cabergoline, Dostinex
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Bioequivalence
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions
The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2 mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States Pharmacopeia (USP), 2 mg (Mylan…
- Trial name
- NCT04411940
- Testing
- Haloperidol Tablets, Mylan Pharmaceuticals Inc., Haloperidol Tablets, Cycle Pharmaceuticals Ltd
- Where
- South Africa
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.