Clinical trials: To Determine the Bioequivalence Study Under Fasting
- Condition To Determine the Bioequivalence Study Under Fasting
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
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
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
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.
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
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.
Hypertension
Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 Under Fasting Conditions
This is a three-period, three sequence, reference replicated, cross-over study to determine the bioequivalence of two amlodipine and losartan FDC tablet formulations FDC5/50 and FDC5/100 (GSK2944406; 5 mg amlodipine and 50 mg and…
- Trial name
- NCT01797926
- Testing
- Reference Treatment: 5 mg amlodipine + 50 mg losartan, Reference Treatment:5 mg amlodipine + 100 mg losartan, FDC 5/50 amlodipine/ losartan
- Where
- South Africa
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Hereditary Tyrosinemia, Type I
Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)
The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1) and Nitisinone 10 mg Tablets 'Baked' for 6 months @ 40°C/75% RH (Test Product 2) are bioequivalent to the reference product Orfadin 10 mg…
- Trial name
- NCT02750345
- Testing
- Nitisinone, Nitisinone Baked Tablet, Orfadin
- Where
- South Africa
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
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
Hypertension
Bioavailability Study of Candesartan Cilexetil 16mg 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
- NCT02006602
- Testing
- Candesartan cilexetil (GW615775, Test formulation), Candesartan cilexetil (Reference treatment)
- Where
- India
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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.
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.
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 Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Industries, Egypt) Versus Myrbetriq 25 mg Extended Release Tablets (Marketed by Astellas Pharma US, Inc, Product of Japan)
An open label randomized, single dose, three way three sequence two treatment partial replicate crossover study to determine the bioequivalence of Mirabegron from Bladogra 50 mg Extended Release film coated tablets (Man by…
- Trial name
- NCT04476966
- Testing
- Bladogra, Myrbetriq (first dosing), Myrbetriq (second dosing)
- Where
- Egypt
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
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
Comparative Bioavailability
Bioequivalence Study of Gliclazide 120 mg Modified Release Tablets
The main purpose of this study is to assess comparative bioavailability of two test formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified release tablet) Manufactured By Indeus Life Sciences…
- Trial name
- NCT02980757
- Testing
- Gliclazide 120 mg MR Tablets Formula A, Gliclazide 120 mg MR Tablets, Gliclazide 120 mg MR Tablets Formula B
- Where
- Jordan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Disphar International B.V.
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