Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study was designed to assess the effect of food on the extent and rate of absorption of Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose combination (Eurartesim™).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: sigma-tau i.f.r. S.p.A.
• Collaborator: CPR Pharma Services Pty Ltd, Australia

Criteria

Inclusion Criteria:

• Caucasian healthy males 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 75 kg.

• Agreed to use two approved methods of contraception from Screening and until 90 days after administration of the study drug

• 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 or an over-the-counter medicine 48 hours prior to the start of dosing.

• Abnormal laboratory test results deemed clinically significant by the Medical Officer.

• Positive urine drug test (e.g. opiates and cannabinoids) or alcohol breath test.

• History of significant drug allergies or significant allergic reaction.

• 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.