Status:
COMPLETED
A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™
Lead Sponsor:
sigma-tau i.f.r. S.p.A.
Collaborating Sponsors:
CPR Pharma Services Pty Ltd, Australia
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 bioavaila...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01222949
Start Date
February 1 2010
End Date
August 1 2010
Last Update
October 18 2010
Active Locations (2)
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1
CMAX, a division of IDT Australia Limited
Adelaide, Australia, SA 5000
2
Nucleus Network Limited
Melbourne, Australia, VIC 3004