- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01112462
To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine
July 6, 2012 updated by: McNeil AB
A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine
This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cork, Ireland
- Shandon Clinical Trials Ltd.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tablet
Paracetamol 500 mg/Phenylephrine 5 mg tablet
|
2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period
Other Names:
|
Active Comparator: Sachet
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic measurements
Time Frame: during 24 hours following drug administration
|
Pharmacokinetic measurements including:
|
during 24 hours following drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
April 27, 2010
First Submitted That Met QC Criteria
April 27, 2010
First Posted (Estimate)
April 28, 2010
Study Record Updates
Last Update Posted (Estimate)
July 10, 2012
Last Update Submitted That Met QC Criteria
July 6, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Diseases
- Respiratory Tract Infections
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Acetaminophen
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- SC02009
- 2009-018093-55 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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