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

NCT03557580 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-06-15

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2018-05-06
Completion
2018-05-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03557580 on ClinicalTrials.gov