A Pharmacokinetic Study of an Experimental Paracetamol Formulation
A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine
1 other identifier
interventional
30
1 country
1
Brief Summary
This PK study is designed to show bioequivalence between the study treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2009
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
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 17, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedNovember 24, 2014
June 1, 2014
1 month
November 17, 2011
November 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
10 hours
Secondary Outcomes (1)
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)
10 hours
Study Arms (2)
Experimental paracetamol formulation
EXPERIMENTALexperimental formulation
paracetamol marketed formulation
ACTIVE COMPARATORParacetamol marketed formulation
Interventions
experimental paracetamol with caffeine
marketed formulation containing caffeine
Eligibility Criteria
You may qualify if:
- Healthy volunteer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
MDS Pharma Services ARIZONA
Phoenix, Arizona, 85044, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2011
First Posted
November 22, 2011
Study Start
July 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
November 24, 2014
Record last verified: 2014-06