Pharmacokinetic Study to Compare Two Formulations of Paracetamol

Pain Clinical Trial

Official title:

A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767428
• Other study ID #: A1900832
• Status: Completed
• Phase: Phase 1
• First received: December 6, 2012
• Last updated: January 10, 2013
• Start date: April 2010
• Est. completion date: April 2010

Study information

• Verified date: January 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: IEC
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever
• Headache Disorders
• Pain

Intervention

Drug:
• Paracetamol
500 mg immediate release paracetamol formulations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	Tmax	Time taken to reach 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.	No