RecruitingPhase 1ACTRN12610000178044

A Phase I, pharmacokinetic trial, in healthy Asian and Caucasian volunteers for investigating the pharmacokinetic profiles of Eurartesim (trademark) (40 mg Dihydroartemisinin/320 mg Piperaquine Phosphate)

A phase 1 pharmacokinetic trial in healthy Asian and Caucasian volunteers, investigating the pharmacokinetic profile of an Anti-Malarial drug - 40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine Phosphate (PQP).


Sponsor

CPR Pharma Services Pty Ltd

Enrollment

20 participants

Start Date

Feb 15, 2010

Study Type

Interventional

Conditions

Summary

The purpose of this study is to test the safety of the drug Eurartesim (trademarked). The drug is to be used for the treatment of uncomplicated Plasmodium Falciparum (a type of malaria, a mosquito borne infectious disease). A number of safety studies have been completed for this new drug, but the company requires more information about what happens when taking this drug in certain groups of people, including the differences between men and women, and the differences between asian and caucasian (western) people and the difference in body weights ( particularly people weighing less than 65 kg and those weighing more than 65kg). The study is to be conducted in helathy people to comapre how the drug behaves in these groups.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and how the body handles a malaria treatment called Eurartesim in healthy Asian and Caucasian volunteers. The study is particularly interested in whether the drug behaves differently between men and women, between Asian and Caucasian people, and between people of different body weights. No participants will actually have malaria — the drug is being tested in healthy people to understand how the body processes it. You may be eligible if: - You are between 18 and 50 years old - You are of Caucasian or Asian background (excluding Indian subcontinent or Middle Eastern) - You are generally healthy with no significant medical conditions - Your BMI is between 19 and 27 kg/m² - You weigh at least 36 kg - You are willing to use two forms of contraception for 90 days after taking the drug You may NOT be eligible if: - You have taken prescription medication in the past 14 days - You are pregnant or breastfeeding - You have significant kidney, liver, heart, or other health problems - You have tested positive for Hepatitis B, Hepatitis C, or HIV - You have participated in a clinical trial within the last 30 days - You have donated blood within the last 90 days - You drink more than 4 units of alcohol daily (men) or 2 units daily (women) - You smoke Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Eurartesim (trademark) is a fixed dose combination tablet for oral administration. Each tablet contains 40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine Phosphate (PQP) On the study each subject re

Eurartesim (trademark) is a fixed dose combination tablet for oral administration. Each tablet contains 40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine Phosphate (PQP) On the study each subject recieves either three or four tablets daily for three consecutive days. The tablets are to be administered following a light breakfast (30 g cornflakes and 250 mL fullfat milk). The number of tablets administered is calculated using the subjects body weight - subjects weighing less than 75 kg are prescribed three tablets and subjects weighing greater than 75 kg are prescribed four tablets.


Locations(1)

Australia

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ACTRN12610000178044