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A Bioequivalence Study Of Ibuprofen 50mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form.

NCT01350596 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-08-03

No results posted yet for this study

Summary

An open label, randomized, 2x2 crossover, single dose, phase 4 study to determine the pharmaceutical bioequivalence of ibuprofen 50mg/ml (laboratórios pfizer ltda) oral suspension versus alivium ® 50mg/ml (mantecorp indústria química e farmacêutica ltda.) Oral suspension, in healthy fasting volunteers.

Conditions

  • Healthy

Interventions

DRUG

Alivium®

400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Reference Drug

DRUG

Ibuprofen

400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Test Drug

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01350596 on ClinicalTrials.gov