NCT02095704

Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Central South University · Academic / Other
• Sex: Male
• Age: 19 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an orally administered solid dosage form. The aim of this study was to evaluate the pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics parameters, investigators trend to propose a method to estimate in vivo dissolution time and dissolution kinetics of solid dosage form.

Conditions

• Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution Studies

Interventions

Type	Name	Description
DRUG	paracetamol oral solution	dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose
DRUG	paracetamol tablet	dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2014-03-26
• Last updated: 2014-03-26