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

NCT05329454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-15

No results posted yet for this study

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.

Conditions

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).

Sponsors & Collaborators

  • Overseas Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Ming-Che Liu, M.D · Taipei Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-24
Primary Completion
2021-02-06
Completion
2021-07-18
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05329454 on ClinicalTrials.gov