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

NCT ID: NCT01222962

Last Updated: 2010-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

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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™).

Detailed Description

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Conditions

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Malaria, Falciparum

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fed treatment

18 healthy volunteers administered with a single dose of Eurartesim

Group Type EXPERIMENTAL

Eurartesim

Intervention Type DRUG

Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 4 Tablets a Day for body weight above 75 kg.

Fasted Treatment

18 healthy volunteers treated with a single dose of Eurartesim

Group Type EXPERIMENTAL

Eurartesim

Intervention Type DRUG

Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 4 Tablets a Day for body weight above 75 kg.

Interventions

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Eurartesim

Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 4 Tablets a Day for body weight above 75 kg.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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CPR Pharma Services Pty Ltd, Australia

INDUSTRY

Sponsor Role collaborator

sigma-tau i.f.r. S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Medical Department, R&D Division, Sigma-Tau ifr SpA

Locations

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CMAX, a division of IDT Australia Limited

Adelaide, , Australia

Site Status

Countries

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Australia

Other Identifiers

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ST3073/ST3074-DM09-008

Identifier Type: -

Identifier Source: org_study_id