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

Overseas Pharmaceuticals, Ltd. · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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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.
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