NCT03557580

A Bioequivalence Study of Isosorbide-5-Mononitrate Extended-Release Tablets Under Fed Conditions in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	IS-5-MN R	single orally dose under fed conditions on day 1 of treatment period 1 for group 1, on day 1 of treatment period 2 for group 2, on day 1 of treatment period 3 for group 3.
DRUG	IS-5-MN T1	single orally dose under fed conditions on day 1 of treatment period 2 for group 1, on day 1 of treatment period 3 for group 2, on day 1 of treatment period 1 for group 3.
DRUG	IS-5-MN T2	single orally dose under fed conditions on day 1 of treatment period 3 for group 1, on day 1 of treatment period 1 for group 2, on day 1 of treatment period 2 for group 3.

Timeline

• Start date: 2018-04-17
• Primary completion: 2018-05-06
• Completion: 2018-05-18
• First posted: 2018-06-15
• Last updated: 2018-06-15

Locations

1 site across 1 country: China