Pharmacokinetic Study to Compare Two Formulations of Paracetamol

NCT01767428 | Completed Phase 1

• 1 other identifier: A1900832
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fever; Headache Disorders; Pain

Outcome Measures

Primary Outcomes (3)

• AUC (0-inf)

  Area under the plasma concentration time curve from zero and extrapolated to infinite time.

  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.

• Cmax

  Maximum plasma concentration of paracetamol.

  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.

• AUC (0-t)

  Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.

  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.

Secondary Outcomes (1)

• Tmax

  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.

Study Arms (2)

Experimental Paracetamol Tablet

EXPERIMENTAL

Experimental paracetamol tablet (500 milligrams \[mg\]) administered with 240 milliliters (mL) of water.

Drug: Paracetamol

Standard Paracetamol Tablet (500 mg)

ACTIVE COMPARATOR

Standard paracetamol tablet (500 mg) administered with 240 mL of water.

Drug: Paracetamol

Interventions

Paracetamol DRUG

500 mg immediate release paracetamol formulations

Experimental Paracetamol Tablet; Standard Paracetamol Tablet (500 mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Fever; Headache Disorders; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: January 14, 2013
• Study Start: April 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 14, 2013

Record last verified: 2013-01