To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mg
Status:
Completed
Trial end date:
2021-07-18
Target enrollment:
Participant gender:
Summary
An open-label, randomized, 3-way crossover study to evaluate the pharmacokinetics of
investigational product "Ibuprofen Modified-Release Tablets 800 mg" in comparison to the
reference standard "Ibuprofen Regular-Release Tablets 600 mg/800 mg" in normal healthy
volunteers
Primary objective:
To evaluate the food effect of IBUMR and its bioavailability of single and multiple doses
compared with reference drugs in normal healthy volunteers.
Secondary objectives:
1. To determine and compare the single and multiple dose PK profiles of IBUMR and reference
drugs.
2. To identify the effect duration for IBUMR after dose administration by detecting
ibuprofen concentrations in plasma.
3. To evaluate the safety profile of single and multiple doses of IBUMR.