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Bioequivalence Study of One Tablet of Paracetamol 1000 mg + Codeine 30 mg vs. Two Tablets of Paracetamol 500 mg + Codeine 30 mg

NCT02902666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2016-09-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the bioequivalence of a new paracetamol 1000 mg/codeine 30 mg formulation vs. the marketed reference Co-efferalgan® 500 mg/30 mg in terms of rate and extent of absorption, when administered as single oral dose (one tablet of the new A.C.R.A.F. formulation vs. two tablets of the reference formulation Co-efferalgan®) to healthy male and female volunteers, under fasting conditions, in two consecutive study periods.

Conditions

  • Healthy

Interventions

DRUG

Paracetamol 1000 mg/codeine phosphate hemihydrate 30 mg tablet

DRUG

Paracetamol 500 mg/codeine phosphate hemihydrate 30 mg tablet

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Principal Investigators

  • Milko Radicioni, MD · Cross Research S.A.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

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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 NCT02902666 on ClinicalTrials.gov