The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
40
single dose 50 mg (2 X 25 mg) artesunate sachets
single dose 50 mg arsuamoon tablet
Pfizer Investigational Site
Navi Mumbai, Maharashtra, India
Cmax, AUCinf and AUClast, for DHA
Time frame: 1 year
Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate.
Time frame: 1 year
Safety laboratory tests, vital signs, and adverse events.
Time frame: 1 year
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