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To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

NCT01112462 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-07-10

No results posted yet for this study

Summary

This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.

Conditions

  • Respiratory Tract Infections

Interventions

DRUG

Paracetamol 500 mg/Phenylephrine 5 mg tablets

2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period

DRUG

Paracetamol 1000 mg/Phenylephrine 10 mg sachet

1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Elisabeth Kruse, PhD · McNeil AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Ireland

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 NCT01112462 on ClinicalTrials.gov