Randomized, 2-way Crossover, Bioequivalence Study of Ibuprofen 200 mg Gel Capsules and Advil Liquigels 200 mg Gel Capsules Administered as 1 x 200 mg Gel Capsules in Healthy Subjects Under Fasting Conditions

Dr. Reddy's Laboratories Limited1 site in 1 country30 target enrollmentNovember 2002

ConditionsHealthy

InterventionsIbuprofen

DrugsIbuprofen

Overview

Phase: Phase 1
Intervention: Ibuprofen
Conditions: Healthy
Sponsor: Dr. Reddy's Laboratories Limited
Enrollment: 30
Locations: 1
Primary Endpoint: Bioequivalence based on Cmax and AUC parameters
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the rate and extent of absorption of ibuprofen 200 mg gelcaps (test) versus Advil liquigels (reference) administered as 1 x 200 mg gelcap under fasting conditions.

Detailed Description

Randomized, 2-way crossover, bioequivalence study of Ibuprofen 200 mg gel capsules and Advil liquigels 200 mg gel caps administered as 1 x 200 mg gel capsule in healthy subjects under fasting conditions.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

November 2002

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Dr. Reddy's Laboratories Limited

Eligibility Criteria

Inclusion Criteria

•Subjects will be females and/or males, smokers and/or non-smokers, 18 years of age and older.

Exclusion Criteria

•Clinically significant illnesses within 4 weeks of the administration of study medication.
•Clinically significant surgery within 4 weeks prior to the administration of the study medication.
•Any clinically significant abnormality found during medical screening.
•Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
•Abnormal laboratory tests judged clinically significant.
•Positive urine drug screen at screening.
•Positive testing for hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) at screening.
•ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.
•Subjects with Body Mass Index (BMI) ≥30.
•History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).