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To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01112462
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):

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

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine
Study Start Date : March 2010
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112462

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

Responsible Party: McNeil AB
ClinicalTrials.gov Identifier: NCT01112462     History of Changes
Other Study ID Numbers: SC02009
2009-018093-55 ( EudraCT Number )
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ):
Nasal congestion, Headache

Additional relevant MeSH terms:
Respiratory Tract Infections
Respiratory Tract Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cardiotonic Agents
Autonomic Agents
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents