Trials / Completed
CompletedNCT01222962
Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers
Study of the Effect of Food on the Pharmacokinetics of DHA and PQP After Single Oral Administration of Eurartesim™ in Healthy Male Adult Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- sigma-tau i.f.r. S.p.A. · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
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™).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2010-05-01
- Completion
- 2010-06-01
- First posted
- 2010-10-18
- Last updated
- 2010-10-18
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT01222962. Inclusion in this directory is not an endorsement.