To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine
A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine
2 other identifiers
interventional
40
1 country
1
Brief Summary
This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 27, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 10, 2012
July 1, 2012
3 months
April 27, 2010
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
during 24 hours following drug administration
Study Arms (2)
Tablet
EXPERIMENTALParacetamol 500 mg/Phenylephrine 5 mg tablet
Sachet
ACTIVE COMPARATORParacetamol 1000 mg/Phenylephrine 10 mg sachet
Interventions
2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period
1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McNeil ABlead
Study Sites (1)
Shandon Clinical Trials Ltd.
Cork, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elisabeth Kruse, PhD
McNeil AB
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2010
First Posted
April 28, 2010
Study Start
March 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
July 10, 2012
Record last verified: 2012-07