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To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

Primary Purpose

Respiratory Tract Infections

Status
Completed
Phase
Phase 1
Locations
Ireland
Study Type
Interventional
Intervention
Paracetamol 500 mg/Phenylephrine 5 mg tablets
Paracetamol 1000 mg/Phenylephrine 10 mg sachet
Sponsored by
McNeil AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Respiratory Tract Infections focused on measuring Nasal congestion, Headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shandon Clinical Trials Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tablet

Sachet

Arm Description

Paracetamol 500 mg/Phenylephrine 5 mg tablet

Paracetamol 1000 mg/Phenylephrine 10 mg sachet

Outcomes

Primary Outcome Measures

Pharmacokinetic measurements
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)

Secondary Outcome Measures

Full Information

First Posted
April 27, 2010
Last Updated
July 6, 2012
Sponsor
McNeil AB
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1. Study Identification

Unique Protocol Identification Number
NCT01112462
Brief Title
To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine
Official Title
A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McNeil AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections
Keywords
Nasal congestion, Headache

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tablet
Arm Type
Experimental
Arm Description
Paracetamol 500 mg/Phenylephrine 5 mg tablet
Arm Title
Sachet
Arm Type
Active Comparator
Arm Description
Paracetamol 1000 mg/Phenylephrine 10 mg sachet
Intervention Type
Drug
Intervention Name(s)
Paracetamol 500 mg/Phenylephrine 5 mg tablets
Other Intervention Name(s)
Sudafed PE Sinus Pain Relief™
Intervention Description
2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period
Intervention Type
Drug
Intervention Name(s)
Paracetamol 1000 mg/Phenylephrine 10 mg sachet
Other Intervention Name(s)
Flu Plus Hot Lemon™ sachet
Intervention Description
1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period
Primary Outcome Measure Information:
Title
Pharmacokinetic measurements
Description
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)
Time Frame
during 24 hours following drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Kruse, PhD
Organizational Affiliation
McNeil AB
Official's Role
Study Director
Facility Information:
Facility Name
Shandon Clinical Trials Ltd.
City
Cork
Country
Ireland

12. IPD Sharing Statement

Learn more about this trial

To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

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