To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mg

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 24, 2020

Primary Completion Date

February 6, 2021

Study Completion Date

July 18, 2021

Conditions
Chronic Pain
Interventions
DRUG

Ibuprofen Tablets

"Treatment A:~One tablet of IBUMR will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBUMR every 12 hours for a total of 7 doses.~Treatment B:~One tablet of IBURed will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBURed every 8 hours for a total of 10 doses.~Treatment C:~Single dose of IBUMR will be given to the subjects under fed condition (a standard high-fat, high calorie breakfast should be consumed within 30 minutes prior to dosing)."

Trial Locations (1)

Unknown

Taipei Medical University Hospital, Taiwan

Sponsors
All Listed Sponsors
lead

Overseas Pharmaceuticals, Ltd.

INDUSTRY

NCT05329454 - To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mg | Biotech Hunter | Biotech Hunter