A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations.

Pain Clinical Trial

Official title:

A Proof of Principal Study to Investigate the Pharmacokinetic Profiles of Sustained Release and Standard Paracetamol Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551797
• Other study ID #: A2750894
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2012
• Last updated: December 6, 2012
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. This study is also used for drug safety evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI): Body Mass Index must be in the range 19-28 kg/m2.

Exclusion Criteria:

• Disease: Current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure).

• Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Paracetamol 500 mg
Standard Paracetamol formulation
• Paracetamol 1000 mg
Paracetamol Sustained Release formulation
• Paracetamol 750 mg
Paracetamol Sustained Release formulation

Locations

Country	Name	City	State
United States	Charles River Clinical Services Northwest, Inc.	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median time to reach therapeutic plasma concentration of paracetamol	Time period in hours over which plasma paracetamol concentration is elevated at or above 4 micrograms (µg)/milliliter (mL).	Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment	No
Secondary	Area under the plasma concentration-time curve (AUC)	Area under the plasma concentration-time curve from zero to 6 hours (AUC 0-6 hours), 12 hours (AUC 0-12 hours) to be determined. AUC0-t : the area under the plasma concentration-time curve from zero to time t when paracetamol remains detectable. AUC0-8: the area under the plasma concentration time curve from zero and extrapolated to infinity time.	Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment	Yes
Secondary	Time to maximum plasma concentration (Tmax)	Tmax for paracetamol to be determined.	Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment	Yes
Secondary	Half-life of elimination (T 1/2)	T 1/2 of paracetamol to be determined.	Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment	Yes
Secondary	Elimination rate (Kel)	Kel of paracetamol to be determined.	Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment	Yes
Secondary	Maximum plasma concentration (Cmax)	Cmax of paracetamol to be determined.	Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment	Yes
Secondary	Number of participants with Adverse Events (AEs) and Serious AEs	Safety evaluation	Day 1 through Day 14 (follow-up visit)	Yes