NCT03557580View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 17, 2018

Primary Completion Date

May 6, 2018

Study Completion Date

May 18, 2018

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.

Trial Locations (1)

Unknown

Qingyuan People's Hospital, Qingyuan

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

NCT03557580 - A Bioequivalence Study of Isosorbide-5-Mononitrate Extended-Release Tablets Under Fed Conditions in Healthy Subjects | Biotech Hunter | Biotech Hunter