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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: November 20, 2014
Last verified: June 2014
  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 Subjects
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
paracetamol

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

ClinicalTrials.gov processed this record on November 25, 2014