FINAL report Penali artemether im. pharmacokinetics

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Study Site: Anonkoua-Kouté (Abidjan), Ivory Coast. Experimental Procedure: Open Controlled Clinical Trial Principal Investigator: Dr. O. André Touré Study Director Dr L. Koné PENALI Co-Investigators: Dr E. W. BEUGRE Dr AKA WOGNIN Data Management and Analysis: Mr T. SERY Sponsor: DAFRA PHARMA Pharmaceutical Support: DAFRA PHARMA External Monitor: F. Herwig Jansen, M.D., Ph.D. Fhj@dafra.be Start of the study: July 2004 Duration of study: 1 month Number of patients included: 23 Collaborating Institutions: a) UNITE DE PALUDOLOGIE- INSTITUT PASTEUR D’ABIDJAN 01 BP 490 ABIDJAN 01 – COTE D’IVOIRE b) DAFRA PHARMA Steenweg op Mol 148 2360 Oud-Turnhout Tel. ++/32/14/61 78 20 Fax ++/32/14/61 78 59 E-mail: info@dafra.be; Fhj@dafra.be 1
1. INTRODUCTION Artemether, an artemisinin derivative, is available in various formulations suitable for the treatment of complicated and non-complicated malaria. We decided to study if there is a difference in plasmalevels of the active compounds of two commercially available intramuscular artemether injections and to compare the results with literature. Since the available literature data is primarily based on research on Asian subjects, with this new study we could generate data in an African population. The two products used were Artesiane (artemether in miglyol) from Dafra and Paluether (artemether in arachis oil) from Aventis-Sanofi. Next to the present study, we studied the clinical efficacy and tolerability of the Artesiane i.m. injection in the treatment of non-complicated malaria with 30 subjects. This study will be reported separately. 2. OBJECTIVES 2. 1. Principal Objective To determine the plasma levels of artemether and dihydroartemisin after administration of an artemether injection in a single dose of 4 mg/kg in patients with non-complicated malaria. 2. 2. Secondary Objectives - none 3. METHODOLOGY 3.1. Study Site: The study site is Anonkoua-Kouté. Ivory Coast is a country located in West Africa. Malaria is endemic (hypo- to hyperendemic), but great variation exists according to the area. Malaria transmission is mainly seasonal and most of the transmission occurs during the rainy season. Anonkoua-Kouté is a peri urban area of Abidjan, the capital city of Ivory Coast. P. falciparum is a predominant species, accounting for more than 95% of malaria cases. 2
Page 1: Open clinical trial: Plasma levels
Page 5 and 6: 3. 7. Data Collection Methods: Data
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Page 9 and 10: 4.2. Plasma levels of individual pa
Page 11 and 12: 4.4. Tmax The Tmax for both formula
Page 13: Looareesuwan et al (2002) Dose-find

FINAL report Penali artemether im. pharmacokinetics

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