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Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg/5ml and Nurofen®, Oral Suspension 100 mg/5 ml in Healthy Volunteers Under Fasting Conditions

NCT03561558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-01

No results posted yet for this study

Summary

To demonstrate bioequivalence of single dose test formulation of Ibuprofen,oral suspension 200 mg/5 ml (containing ibuprofen 200 mg) of Pharmtechnology LLC, Republic of Belarus with reference Nurofen® for Children, oral suspension 100 mg / 5 ml (containing ibuprofen 100 mg) of "Reckitt Benckiser Healthcare International Ltd, .", UK in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety

Conditions

  • Healthy

Interventions

DRUG

Ibuprofen D

Ibuprofen D, oral suspension, 200 mg / 5ml, manufactured by LLC Pharmtechnology, Belarus

DRUG

Nurofen® for Children

Nurofen® for Children, Oral Suspension, 100 mg / 5 ml, marketed by Reckitt Benckiser Healthcare International Ltd, UK

Sponsors & Collaborators

  • ClinPharmInvest, LLC

    collaborator OTHER

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Alexander Khokhlov, Professor · ClinPharmInvest, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2018-06-24
Completion
2018-06-25

Countries

  • Russia

Study Locations

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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 NCT03561558 on ClinicalTrials.gov