Status:
COMPLETED
A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations
Lead Sponsor:
GlaxoSmithKline
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A repeat dose pharmacokinetic study investigating two paracetamol formulations
Eligibility Criteria
Inclusion
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Exclusion
- Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01476189
Start Date
November 1 2009
End Date
December 1 2009
Last Update
November 24 2014
Active Locations (1)
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1
MDS Pharma Services NEBRASKA
Lincoln, Nebraska, United States, 68501