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

Sigma-Tau Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Malaria, Falciparum

Treatments

Drug: Eurartesim

Study type

Interventional

Funder types

Industry

Identifiers

NCT01222962

ST3073/ST3074-DM09-008

Details and patient eligibility

About

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™).

Enrollment

37 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.