Health Condition 1: null- Plasmodium falciparum malaria
Conditions
Interventions
Intervention1: Novel formulation of Artesunate Injection: Novel formulation of Artesunate Injection 2.4mg/kg body weight I.V. to be administered at 0 hr then at 12 hr and 24 hr.Total duration of treat
Sponsors
Ipca Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects in the age range of 18-65 years (both inclusive) 2. Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition. 3. Patients with signs and symptoms of malaria and confirmation of diagnosis by positive blood smear test with asexual forms of Plasmodium falciparum with count equal to or more than 10,000 parasites per ul of blood and requiring parenteral therapy 4. Patient must understand and be able, willing, and likely to fully comply with study procedures and restrictions 5. Patient willing to come for study follow up as required by study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with febrile disease other than malaria 2. Patients with mixed malarial infections 3. Patient with severe malaria 4. Patients with abnormal heart function 5. Pregnant or lactating women. 6. Women of childbearing potential not practicing contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure RateTimepoint: 28-day | — |
Secondary
| Measure | Time frame |
|---|---|
| Fever Clearence TimeTimepoint: Every 6 hours;Parasite Clearence TimeTimepoint: Every 12 hours | — |
Countries
India
Contacts
Public ContactMr Nitin Chandurkar
Ipca Laboratories Limited
Outcome results
None listed