Clinical trials: To Determine the Bioequivalence Study Under Fasting
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
Healthy
Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Gabapentin From Nerpentin 600 mg (Test ) F.C.T (Aman Pharma ,Egypt.) and Gabapentin From Neurontin 300 mg (Referance ) H.G.C. ( Pfizer Egypt)
This study is conducted with the aim to investigate whether any differences concerning the rate and extent of absorption exist between the test and the reference product, Test product was Nerpentine 600 mg Film coated Tablet…
- Trial name
- NCT04805827
- Testing
- Gabapentin, Neurontin
- Where
- Egypt
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharma Guide CRO
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
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 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.
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
Bioequivalence
Bioequivalence Study of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® 75 mg Tablet After Oral Administration to Healthy Adult Subjects Under Fasting Condition
To compare the rate and extent of absorption of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® (clopidogrel) 75 mg tablet under fasting condition.
- Trial name
- NCT05186129
- Testing
- Clopid® 75 mg Tablet, Plavix® 75mg Tablet
- Where
- Pakistan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Center for Bioequivalence Studies and Clinical Research
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
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
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
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.
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 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
Healthy
Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
- Trial name
- NCT02767310
- Testing
- Rosuvastatin 20 mg film-coated tablets, Crestor 20 mg film-coated tablets
- Where
- India
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
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
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
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
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
To Determine the Bioavailability of Tranylcypromine
Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions
To compare the single-dose Bioavailability of Tranylcypromine and Parnate
- Trial name
- NCT00653393
- Testing
- Tranylcypromine, Parnate
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
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.