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A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476215
First received: November 3, 2011
Last updated: January 24, 2013
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Paracetamol fast dissolution suspension
Drug: Paracetamol medium dissolution suspension
Drug: Paracetamol slow dissolution suspension
Drug: Paracetamol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to plasma level above therapeutic level [ Time Frame: baseline to 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General PK parameters (e.g. AUC, Tmax, Cmax) [ Time Frame: baseline to 8 hours ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fast dissolution suspension Drug: Paracetamol fast dissolution suspension
Experimental: Medium dissolution suspension Drug: Paracetamol medium dissolution suspension
Experimental: Slow dissolution suspension Drug: Paracetamol slow dissolution suspension
Active Comparator: Marketed suspension Drug: Paracetamol

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer
  • Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476215

Locations
United States, Nebraska
MDS Pharma Services NEBRASKA
Lincoln, Nebraska, United States, 68501
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01476215     History of Changes
Other Study ID Numbers: A3950669
Study First Received: November 3, 2011
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
paracetamol

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013