Status:
COMPLETED
Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers
Lead Sponsor:
sigma-tau i.f.r. S.p.A.
Collaborating Sponsors:
CPR Pharma Services Pty Ltd, Australia
Conditions:
Malaria, Falciparum
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief 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 (Eurartesi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01222962
Start Date
March 1 2010
End Date
June 1 2010
Last Update
October 18 2010
Active Locations (1)
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1
CMAX, a division of IDT Australia Limited
Adelaide, Australia, SA 5000