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Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets

NCT03429738 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-02-12

No results posted yet for this study

Summary

Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions.

Conditions

  • Pain, Head
  • Pain, Acute
  • Pain, Back
  • Fever

Interventions

DRUG

Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets

Experimental drug

DRUG

RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets

Active Comparator

Sponsors & Collaborators

  • Pharma Medica Research, Inc.

    collaborator INDUSTRY

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Latifa Yamlahi, MD · Pharma Medica Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-27
Primary Completion
2014-05-05
Completion
2014-05-05

Countries

  • Canada

Study Locations

More Related Trials

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 NCT03429738 on ClinicalTrials.gov