NCT05329454

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

An Open-label, Randomized, 3-way Crossover Study to Evaluate the Pharmacokinetics of Investigational Product Ibuprofen Modified-Release Tablets 800 mg Compared to Ibuprofen Tablets 800 mg in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Overseas Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study consists of 3 treatment periods as below. For Treatment A and Treatment B, single- and multiple-dose stages are included. 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 8 doses. Treatment B: One tablet of IBURed-800mg 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-600mg every 8 hours for a total of 12 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). A minimum of 3-day washout interval will be introduced across the 3 treatment periods. Subjects will be required to be fasted for at least 10 hours prior to the administration of morning doses.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-12-24
• Primary completion: 2021-02-06
• Completion: 2021-07-18
• First posted: 2022-04-15
• Last updated: 2022-04-15

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study