MedTrace Logo

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

NCT03418805 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-04-01

No results posted yet for this study

Summary

To evaluate the food effect of Ibuprofen CR Tablets 600 mg (IBUCR), and its bioavailability comparison versus 3 doses of the reference arms including Advil® Ibuprofen Tablets 200 mg (IBUAdv) and Motrin® IB Ibuprofen Tablets 200 mg (IBUMot) in normal healthy volunteers.

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

Sponsors & Collaborators

  • Virginia Contract Research Organization Co., Ltd.

    collaborator OTHER

  • Overseas Pharmaceuticals, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-11
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

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 NCT03418805 on ClinicalTrials.gov