A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
NCT01476215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2014-11-24
Summary
This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
Paracetamol fast dissolution suspension
- DRUG
-
Paracetamol medium dissolution suspension
- DRUG
-
Paracetamol slow dissolution suspension
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2009-11-30
- Completion
- 2009-11-30
Countries
- United States
Study Locations
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