title: Pharmacokinetics of artesunate alone and in combination with sulfadoxine/pyrimethamine in healthy Sudanese volunteers.
abstract: Artesunate (AS) in combination with sulfadoxine/pyrimethamine (SP) is the first-line therapy for management of uncomplicated Plasmodium falciparum malaria in Sudan. The objective of this study was to assess the potential impact of SP on the pharmacokinetics of AS and its active metabolite, dihydroartemisinin (DHA), in healthy adults. A single-dose, randomized, open-label, crossover study design with a washout period of three weeks was performed with 16 volunteers. After oral administration of AS alone or in combination with SP, Tmax values of AS and DHA were significantly prolonged in the combination group (P < 0.05). However, there was no significant effect on the other pharmacokinetic parameters (P > 0.05). The t1/2 values of AS and DHA were significantly higher in females than in males (P < 0.05). The present findings suggest that co-administration of SP with AS has no clinically relevant impact on the pharmacokinetics of AS or DHA in healthy persons.
authors.affiliation: Department of Pharmacology and Therapeutics, and Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait; National Medicines and Poisons Board, Khartoum, Sudan kamal@hsc.edu.kw.
authors.forename: Kamal M
authors.initials: KM
authors.lastname: Matar
authors.affiliation: Department of Pharmacology and Therapeutics, and Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait; National Medicines and Poisons Board, Khartoum, Sudan.
authors.forename: Abdelmoneim I
authors.initials: AI
authors.lastname: Awad
authors.affiliation: Department of Pharmacology and Therapeutics, and Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait; National Medicines and Poisons Board, Khartoum, Sudan.
authors.forename: Sakina B
authors.initials: SB
authors.lastname: Elamin
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000962:Antimalarials / Q000008:administration & dosage / Q000493:pharmacokinetics*; D037621:Artemisinins / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000077332:Artesunate; D018592:Cross-Over Studies; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D010963:Plasmodium falciparum / Q000187:drug effects*; D011739:Pyrimethamine / Q000493:pharmacokinetics*; D013397:Sudan; D013413:Sulfadoxine / Q000493:pharmacokinetics*; D014838:Volunteers; D055815:Young Adult
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; C001205:fanasil, pyrimethamine drug combination; D000077332:Artesunate; C039060:artenimol; D013413:Sulfadoxine; D011739:Pyrimethamine