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To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01112462
First received: April 27, 2010
Last updated: July 6, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Respiratory Tract Infections
 Drug: Paracetamol 500 mg/Phenylephrine 5 mg tablets
Drug: Paracetamol 1000 mg/Phenylephrine 10 mg sachet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Pharmacokinetic measurements [ Time Frame: during 24 hours following drug administration ] [ Designated as safety issue: No ]

    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)


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tablet
Paracetamol 500 mg/Phenylephrine 5 mg tablet
 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
Other Name: Sudafed PE Sinus Pain Relief™
Active Comparator: Sachet
Paracetamol 1000 mg/Phenylephrine 10 mg sachet
 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
Other Name: Flu Plus Hot Lemon™ sachet

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112462

Locations
Ireland
Shandon Clinical Trials Ltd.
Cork, Ireland
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01112462     History of Changes
Other Study ID Numbers: SC02009, 2009-018093-55
Study First Received: April 27, 2010
Last Updated: July 6, 2012
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Nasal congestion, Headache

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Acetaminophen
Phenylephrine
Oxymetazoline
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
 Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Cardiovascular Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013