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| Name | Class |
|---|---|
| CPR Pharma Services Pty Ltd, Australia | INDUSTRY |
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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 (Eurartesimâ„¢).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fed treatment | Experimental | 18 healthy volunteers administered with a single dose of Eurartesim |
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| Fasted Treatment | Experimental | 18 healthy volunteers treated with a single dose of Eurartesim |
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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). 4 Tablets a Day for body weight above 75 kg. |
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| Measure | Description | Time Frame |
|---|---|---|
| tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, λz, t1/2, Cl/F, Vz/F [DHA]. | Blood samples for determination of plasma DHA were collected at the following times: At pre-dose Day 0 and then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose. Blood samples for determination of plasma PQ were collected at the following times: At pre-dose Day 0 and then at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose; on Day 1, 2, 3, 4, 5 and 7. | from the day of study drug administration, till Day 7 follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events | Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period | Day 0 and till Day 30 follow-up |
| 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 |
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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 2, day 30 |
| 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 2, day 30 |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |