A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations

NCT01476189 | Completed Phase 1

• 1 other identifier: A2750607
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A repeat dose pharmacokinetic study investigating two paracetamol formulations

Conditions

Healthy Subjects

Keywords

pharmacokinetic; paracetamol; Healthy volunteer; steady state

Outcome Measures

Primary Outcomes (1)

• Bioequivalence as measured by Area Under the Curve (AUC)

  last 24 hours of dosing

Secondary Outcomes (3)

• Time duration at or above minimal therapeutic plasma paracetamol concentration

  last 24 hours of dosing

• To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)

  last 24 hours of dosing

• Adverse events

  Baseline to 72 hours post dosing

Study Arms (3)

Experimental paracetamol formulation

EXPERIMENTAL

test formulation

Drug: Experimental paracetamol formulation

Marketed paracetamol

ACTIVE COMPARATOR

Marketed paracetamol

Drug: Marketed paracetamol

Higher dose marketed paracetamol

ACTIVE COMPARATOR

higher dose marketed paracetamol

Drug: Higher dose marketed paracetamol

Interventions

Experimental paracetamol formulation DRUG

experimental

Experimental paracetamol formulation

Marketed paracetamol DRUG

Marketed paracetamol

Marketed paracetamol

Higher dose marketed paracetamol DRUG

Higher dose marketed paracetamol

Higher dose marketed paracetamol

Eligibility Criteria

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

You may qualify if:

• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

You may not qualify if:

• Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
• Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
• Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

MDS Pharma Services NEBRASKA

Lincoln, Nebraska, 68501, United States

Location

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 24, 2014

Record last verified: 2014-06

Locations

US (1)