Trial | NCT01222949  Report issue

Title

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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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.
Study Started
Feb 28
2010
Primary Completion
Jul 31
2010
Study Completion
Aug 31
2010
Last Update
Oct 18
2010
Estimate

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.

Asian Healthy Volunteers Experimental

Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects)

Caucasian Healthy Volunteers Experimental

Caucasian males with a body weight ≤ 65 kg (12 subjects) Caucasian females with a body weight ≤ 65 kg (12 subjects) Caucasian males with a body weight > 65 kg (24 subjects)

Criteria 

Inclusion Criteria:

Caucasian or Asian healthy subjects, Male or female, aged between 18 and 50 years (inclusive)
Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum body weight of 36 kg.
Agreed to use two approved methods of contraception
Had given written informed consent to participate in this study in accordance with local regulations

Exclusion Criteria:

Had received or was anticipated to receive a prescription medication within 14 days prior to the start of dosing
Pregnant or lactating (females only)
Abnormal laboratory test results deemed clinically significant at screening
Positive urine drug test or alcohol breath test
Acute therapy for a serious infection within 30 days of study entry
History of significant drug allergies or significant allergic reactions
Had participated in a clinical trial or had received an experimental therapy within 30 days or 10 half-lives of the drug
Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration
No Results Posted