NCT01381640
Withdrawn
Phase 1
A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula
ConditionsHealthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Experimental paracetamol formulation
- Conditions
- Healthy Subjects
- Sponsor
- GlaxoSmithKline
- Locations
- 2
- Primary Endpoint
- Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male subjects who are in good general health
- •Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental paracetamol formulation
Experimental formulation
Intervention: Experimental paracetamol formulation
Marketed paracetamol
Marketed formulation
Intervention: Marketed paracetamol
Outcomes
Primary Outcomes
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
Time Frame: Baseline to 12 hours post dosing
Secondary Outcomes
- To assess the gastrointestinal transit by qualitative scintigraphic analysis(Baseline to 12 hours post dosing)
Study Sites (2)
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