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A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™

NCT ID: NCT01222949

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-08-31

Brief Summary

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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 bioavailability of DHA and PQ.

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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Asian Healthy Volunteers

Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects)

Group Type EXPERIMENTAL

Eurartesim

Intervention Type DRUG

Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 3 Tablets a Day for body weight comprised between 36 and 75 kg, 4 tablets for body weight above 75 kg.

Caucasian Healthy Volunteers

Caucasian males with a body weight ≤ 65 kg (12 subjects) Caucasian females with a body weight ≤ 65 kg (12 subjects) Caucasian males with a body weight \> 65 kg (24 subjects)

Group Type EXPERIMENTAL

Eurartesim

Intervention Type DRUG

Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 3 Tablets a Day for body weight comprised between 36 and 75 kg, 4 tablets 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). 3 Tablets a Day for body weight comprised between 36 and 75 kg, 4 tablets for body weight above 75 kg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

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

Nucleus Network Limited

Melbourne, , Australia

Site Status

Countries

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Australia

Other Identifiers

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ST3073/ST3074-DM09-007

Identifier Type: -

Identifier Source: org_study_id