Bioequivalence Clinical Trial
Official title:
A Randomized, Open Label, Balanced, Single Dose, 3-way Crossover Bioequivalence Study of Two Isosorbide -5 -Mononitrate Extended -Release Tablets 40 mg and ISMO Retard 40 mg Under Fed Conditions in Healthy Subjects
The purpose of this trial is to compare the pharmacokinetic characteristics of two isosorbide
-5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd and ISMO
Retard (isosorbide -5 -mononitrate extended -release tablet) 40 mg, distributed by RIEMSER
Pharma GmbH.
Primary endpoints are Cmax, AUC(0-t) and AUC(0-inf). Secondary endpoints are Tmax, t1/2 and
λz.
Objectives: Primary Objective: To compare the pharmacokinetic characteristics of two
isosorbide -5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd,
China and ISMO Retard (isosorbide -5 -mononitrate extended -release tablet) 40 mg,
distributed by RIEMSER Pharma GmbH. following a single oral dose administration in healthy
Chinese subjects under fed condition.
Secondary Objective: To monitor the safety profile of the subjects exposed to the
Investigational Medicinal Product.
Study Design: a randomized, open label, balanced, 3-way crossover, single dose study under
fed conditions.12 subjects will be randomized to one of the 3 treatment sequences. Each
treatment sequence will consist of 3 periods, separated by a washout period of at least 7
days. For sequence 1, first reference drug, then test formulation 1 and test formulation 2
will be administered. The order for sequence 2 is test formulation 2, reference drug and test
formulation 1. The order for sequence 3 is test formulation 1, test formulation 2 and
reference drug.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03705533 -
Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State
|
Phase 1 | |
| Completed |
NCT04938856 -
Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions
|
Phase 1 | |
| Completed |
NCT03646331 -
Bioequivalence of Imeglimin Tablet Formulations
|
Phase 1 | |
| Completed |
NCT04564456 -
A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05197517 -
Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition
|
Phase 1 | |
| Completed |
NCT03702894 -
Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions
|
Phase 1 | |
| Withdrawn |
NCT02894515 -
Bioequivalence Study of Idalopirdine in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03018015 -
Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
|
Phase 1 | |
| Completed |
NCT02206295 -
Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg
|
Phase 1 | |
| Completed |
NCT01331993 -
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
|
Phase 1 | |
| Completed |
NCT01260805 -
A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.
|
Phase 1 | |
| Recruiting |
NCT06066112 -
Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body
|
Phase 1 | |
| Completed |
NCT05477810 -
Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions
|
Early Phase 1 | |
| Completed |
NCT04546256 -
A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05083325 -
Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product
|
Phase 1 | |
| Completed |
NCT05061901 -
Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions
|
Phase 1 | |
| Recruiting |
NCT04138888 -
A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions
|
Phase 1 | |
| Completed |
NCT05145621 -
Oral Bio-equivalence Study
|
Phase 1 | |
| Completed |
NCT06124560 -
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
|
Phase 1 | |
| Completed |
NCT03340753 -
Bioavailability of KBP-5074 Tablet vs Capsule Formulations
|
Phase 1 |