Clinical trials: To Determine Bioequivalence Under Fasting Conditions
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
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.
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
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
Healthy
Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions
Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 mg ODT
- Trial name
- NCT00659685
- Testing
- Ondansetron, Zofran ODT
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Acute Myeloid Leukaemia
Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)
A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated…
- Trial name
- NCT06326697
- Testing
- Azacitidine, Onureg
- Where
- Saudi Arabia
- Volunteers
- 32 people
- Sponsor
- Hikma Pharmaceuticals LLC
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
- Trial name
- NCT00653419
- Testing
- buspirone HCl, Buspar
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
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
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
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 Bioequivalence Under Fasting Conditions
Bioavailability Study of Torsemide Tablets Under Fasting Conditions
To compare the single-dose bioavailability of Torsemide tablets with Demadex
- Trial name
- NCT00653549
- Testing
- Torsemide, Demadex
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting 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
- NCT00653380
- Testing
- Doxycycline Monohydrate, Monodox
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
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.