NCT01222949

A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™

A Phase I, Pharmacokinetic Trial, in Healthy Asian and Caucasian Volunteers for Investigating the Pharmacokinetic Profiles of Eurartesim™ (40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine (PQ) Phosphate.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: sigma-tau i.f.r. S.p.A. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the relative bioavailability of DHA and PQ.

Conditions

• Malaria, Falciparum

Interventions

Type	Name	Description
DRUG	Eurartesim	Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 3 Tablets a Day for body weight comprised between 36 and 75 kg, 4 tablets for body weight above 75 kg.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2010-10-18
• Last updated: 2010-10-18

Locations

2 sites across 1 country: Australia