To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers

PHASE1TerminatedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

December 11, 2017

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2020

Conditions
Pain Control
Interventions
DRUG

Advil Ibuprofen table 200 mg

"Administration of the comparator drug:~Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration."

DRUG

Motrin IB Ibuprofen Tablets 200 mg

"Administration of the comparator drug:~Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration."

DRUG

Ibuprofen CR Tablets 600 mg

"Administration of the investigational product:~Single oral dose of IBUCR, followed by 28 and 32 hours after the dose administration for fasted and fed studies, respectively"

Trial Locations (1)

Unknown

Tri-Service General Hospital, Taipei

Sponsors
All Listed Sponsors
lead

Overseas Pharmaceuticals, Ltd.

INDUSTRY

collaborator

Virginia Contract Research Organization Co., Ltd.

OTHER

NCT03418805 - To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers | Biotech Hunter | Biotech Hunter