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Completed

NCT Number: NCT01112462

To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

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

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Key information

Conditions

Respiratory Tract Infections Airway Obstruction Headache Infections Nasal Obstruction Neurologic Manifestations Nose Diseases Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shandon Clinical Trials Ltd.

Cork, Ireland

About this study

The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females. Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 days. In each study period, sixteen blood samples for pharmacokinetic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of paracetamol and phenylephrine in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female
  • Caucasians
  • Aged between 18 and 50 years
  • BMI ≤ 30 kg/m2
  • Clinically normal medical history
  • Physical normal examination
  • Normal laboratory test results

Exclusion criteria

  • Pregnancy, lactation or intended pregnancy
  • Hypersensitivity to or intolerant of the study medications
  • Donation or loss of blood within 90 days preceding the first dose of study medication

Treatment and study plan

Paracetamol 500 mg/Phenylephrine 5 mg tablets

Drug

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

Other names: Sudafed PE Sinus Pain Relief™

Paracetamol 1000 mg/Phenylephrine 10 mg sachet

Drug

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

Other names: Flu Plus Hot Lemon™ sachet

Primary outcomes

  1. Pharmacokinetic measurements

    Time frame: during 24 hours following drug administration

    Pharmacokinetic measurements including:

    • Cmax (Maximum concentration)
    • AUC0-t (Area under the plasma concentration versus time curve from 0h to the lastmeasurable concentration)
    • AUC0-inf (Area under the plasma concentration versus time curve from 0h to infinity)

Sponsors and collaborators

Lead sponsor

McNeil AB

Industry

Registry information

Official study title

A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 28, 2010
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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