Pharmacokinetic Study to Compare Two Formulations of Paracetamol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01767428
First received: December 6, 2012
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.


Condition Intervention Phase
Fever
Headache Disorders
Pain
Drug: Paracetamol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • AUC (0-inf) [ Time Frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. ] [ Designated as safety issue: No ]
    Area under the plasma concentration time curve from zero and extrapolated to infinite time.

  • Cmax [ Time Frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. ] [ Designated as safety issue: No ]
    Maximum plasma concentration of paracetamol.

  • AUC (0-t) [ Time Frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. ] [ Designated as safety issue: No ]
    Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.


Secondary Outcome Measures:
  • Tmax [ Time Frame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. ] [ Designated as safety issue: No ]
    Time taken to reach maximum plasma concentration of paracetamol.


Enrollment: 30
Study Start Date: April 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Paracetamol Tablet
Experimental paracetamol tablet (500 milligrams [mg]) administered with 240 milliliters (mL) of water.
Drug: Paracetamol
500 mg immediate release paracetamol formulations
Active Comparator: Standard Paracetamol Tablet (500 mg)
Standard paracetamol tablet (500 mg) administered with 240 mL of water.
Drug: Paracetamol
500 mg immediate release paracetamol formulations

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study
  • BMI must be within the range 18.5 - 24.9 kg/m^2
  • Participant with a minimum weight of 50 kg

Exclusion Criteria:

  • Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)
  • Participant with known or suspected intolerance or hypersensitivity to the study materials
  • Participant who are vegetarian
  • Participant smoking more than five cigarettes a day
  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: NCT01767428

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01767428     History of Changes
Other Study ID Numbers: A1900832
Study First Received: December 6, 2012
Last Updated: January 10, 2013
Health Authority: India: IEC

Additional relevant MeSH terms:
Headache Disorders
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
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 July 29, 2014