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| Name | Class |
|---|---|
| CPR Pharma Services Pty Ltd, Australia | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asian Healthy Volunteers | Experimental | Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects) |
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| Caucasian Healthy Volunteers | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eurartesim | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, t1/2 | DHA evaluation: At pre-dose on day Day 0 and Day 2 and then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose. PQ evaluation: At pre-dose Day 0 and then at 1, 2, 3, 4, 5, 6, 8, 12, and 16 hours post-dose; then at pre-dose Day 1 and Day 2 and finally at 1, 2, 3, 4, 5, 6, 8, 12, and 16 hours post-dose on day 2; on Day 3, 4, 5, 7, 14, 21, 28, 42, 56 and 90. | During the first and last day of drug administration (day 0 and 2) and followed up till Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) | Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period | From Day 0 till Day 90 |
| Hematology and blood chemistry changes respect to baseline values |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX, a division of IDT Australia Limited | Adelaide | SA 5000 | Australia | |||
| Nucleus Network Limited |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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Abnormalities in hematology (Haemoglobin, Hematocrit,RBC count, White cell count and differential count, Platelets) and clinical chemistry (Protein, Sodium, Potassium, Chloride ,Total Bilirubin, Conjugated Bilirubin, Alanine Aminotransferase, Aspartate Aminotransferase, Total Cholesterol, Glucose, Bicarbonate, Urea, Urate, Lactate Dehydrogenase, Albumin, Globulins, Triglycerides, Creatinine, Alkaline Phosphatase, Gamma glutamyltransferase, Total Calcium, Phosphate, C-reactive protein) will be recorded the day of the last study drug intake and after 30 days from the start of the drug treatment
| Day 0, Day 3, Day 28, Day 90 |
| QTc interval prolongation | ECG recordings will be obtained at baseline, after the last drug intake and 30 days follow-up to investigate changes in ECG parameters, and specifically QTc interval changes respect to baseline | Day 0, day 3, day 28, day 90 |
| Melbourne |
| VIC 3004 |
| Australia |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |