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Sex Affects the Steady-State Pharmacokinetics of Primaquine but Not Doxycycline in Healthy Subjects

We evaluated whether sex affects the steady-state pharmacokinetics of the antimalarial drugs, primaquine and doxycycline, in healthy subjects. Seventeen male and 17 female healthy Vietnamese subjects were administered 30 mg (base) of primaquine daily for 14 days. After a 2-week washout period, 14 male and 14 female subjects were administered 100 mg (base) of doxycycline daily for 14 days. Women had significantly higher median values of C_max (212 versus 122 ng/mL, P< 0.001) and AUC_0–24 (1,909 versus 917 ng · h/mL, P < 0.001) of primaquine compared with men. Other than a longer t_max in women, no sex-related differences were seen in the pharmacokinetics of doxycycline. The primaquine pharmacokinetic data suggest that women have increased exposure to primaquine, which may put them at increased risk for toxicity when administered the same maintenance dose as men. The similar pharmacokinetics of doxycycline between the two sexes justifies the same maintenance dose.

Received April 24, 2009. Accepted for publication July 20, 2009.

Acknowledgments: This study was carried out under the auspices of the Vietnam Australia Defence Malaria Project, a defence cooperation between the Vietnam People’s Army and the Australian Defence Force. The authors thank the Vietnam People’s Army Department of Military Medicine for supporting the study and the financial sponsor, the Australian Defence Force Strategic International Policy Division. The authors are most grateful to Dr. Duy Anh for his administrative support at Central Military Hospital 108, Dr. Chu Xuan Anh for assisting in the conduct of the study and the technical excellence of Nguyen Minh Thu and her nursing colleagues at Central Military Hospital 108 for the blood collections. The authors thank Dinh Thi Viet Lien and Hamish Barbour for doxycycline measurements and Dr. Le Ngoc Anh for administrative/logistic support. We are grateful to Professor G. Dennis Shanks and Dr. Bob Cooper for commenting on the manuscript.

Disclaimer: The opinions expressed are those of the authors and do not necessarily reflect those of the Joint Health Command or any extant of the Australian Defence Force health policy.

^* Address correspondence to Michael D. Edstein, Australian Army Malaria Institute, Enoggera, Brisbane, Queensland 4051, Australia. E-mail: Mike.Edstein{at}defence.gov.au

Authors’ addresses: Vu Quoc Binh, Nguyen Xuan Thanh and Bui Dai, Department of Malaria, Military Institute of Hygiene and Epidemiology, Hanoi, Vietnam. Nguyen Trong Chinh, Bui Tri Cuong and Nguyen Ngoc Quang, Department of Infectious Disease, Central Military Hospital, Hanoi, Vietnam. Thomas Travers and Michael D. Edstein, Department of Drug Evaluation, Australian Army Malaria Institute, Brisbane, Queensland, Australia.