Clinical trials: To Determine the Bioequivalence Study Under Fasting
- Condition To Determine the Bioequivalence Study Under Fasting
- Funder type Industry (pharma, biotech, devices)
To Determine the Bioequivalence Study Under Fasting
Bioavailability Study of Leflunomide Tablets Under Fasting Conditions
To compare the single-dose Bioavailability of Kali and Aventis
- Trial name
- NCT00652665
- Testing
- Leflunomide, ARAVA
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Gastrointestinal Diseases
A Bioequivalence Study of Idiazole 20mg DR Tabs and PARIET® 20 mg DR Tabs After a Single Oral Dose Administration Under Fasting Conditions in Healthy Adults
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
- NCT02446483
- Testing
- Idiazole 20mg DR tabs, PARIET 20 mg DR tabs
- Where
- Egypt
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
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.
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions
To compare the relative bioavailability of Kali and Ortho-McNeil's
- Trial name
- NCT00653315
- Testing
- Tramadol APAP, Ultracet
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Bioequivalence Study of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical…
- Trial name
- NCT05135793
- Testing
- Topoprazan, Takecab
- Where
- Egypt
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
To Determine the Bioequivalence Under Fasting Conditions
Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions
-To compare the single dose bioavailability of Kali and BTG
- Trial name
- NCT00652886
- Testing
- Oxandrolone, Oxandrin
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
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
Hereditary Tyrosinemia, Type I
Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin
The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1 (TP1)) and Nitisinone 10 mg Tablets High Compritol (Test Product 2 (TP2)) are bioequivalent to the reference product Orfadin 10 mg…
- Trial name
- NCT02750709
- Testing
- Nitisinone, Nitisinone 10 mg Tablet High Compritol, Orfadin
- Where
- South Africa
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Hypertension
Bioavailability Study of Candesartan Cilexetil 8mg Tablet Under Fasting Conditions
This will be an open-label, randomized, single dose, two-way crossover study. Each subject will participate in both treatment periods and will receive single oral doses of candesartan cilexetil (GW615775) and reference…
- Trial name
- NCT02006589
- Testing
- Candesartan cilexetil (GW615775, Test formulation), Candesartan cilexetil (Reference treatment)
- Where
- India
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
Smoking Cessation
Single-Dose Bioequivalence Study Comparing Two 4 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
- NCT03432312
- Testing
- Nicotine lozenge
- Where
- South Africa
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Fertin Pharma A/S
To Determine the Bioequivalence Study Under Fasting
Bioavailability Study of Metronidazole Capsules Under Fasting Conditions
The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D. Searle, Inc.
- Trial name
- NCT01380509
- Testing
- Metronidazole, Flagyl
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Fasting
Bioequivalence Study of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet
The primary objective of this study is to assess the bioequivalence between the test product and the reference product based on Cmax and AUC0->72 for sulfadoxine and pyrimethamine in healthy adults under fasting conditions.
- Trial name
- NCT06522763
- Testing
- Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets., Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ
- Where
- Jordan
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Swiss Pharma Nigeria Limited
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
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
Allergy
Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg
A SINGLE CENTER, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, TWO PERIOD CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO INHALATION FORMULATIONS CONTAINING BUDESONIDE 200 µg ADMINISTERED AS 3 PUFFS (TOTAL DOSE OF 600 µg) IN AT…
- Trial name
- NCT02593500
- Testing
- Budesonida Pulmictan® 200 µg, Budesonide 200 µg
- Where
- South Africa
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Reig Jofre Group
Gastritis
A Pilot Study to Determine the Relative Bioavailability of Mosapride 5mg From Two Candidate Formulations of GR107719B Relative to One 5mg Tablet of Reference Mosapride Citrate (GASMOTIN™) in Healthy Adult Human Subjects Under Fasting Conditions
This study aims to determine the relative bioavailability of two candidate formulations of mosapride citrate 5mg tablets compared the reference product GASMOTIN (mosapride citrate 5mg) from Dainippon Pharmaceutical Company in…
- Trial name
- NCT02201316
- Testing
- Reference mosapride citrate (GASMOTIN), GR107719B (Formulation 1), GR107719B (Formulation 2)
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline