Healthy Volunteers
Conditions
Keywords
Bioequivalence study-artesunate sachets-arsuamoon tablet
Brief summary
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).
Interventions
DRUGartesunate sachets
single dose 50 mg (2 X 25 mg) artesunate sachets
DRUGArsuamoon
single dose 50 mg arsuamoon tablet
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs). * An informed consent document signed and dated by the subject or a legally acceptable representative.
Exclusion criteria
* Any condition possibly affecting drug absorption. * A positive urine drug screen. * Have a known history of hypersensitivity, allergy (except for untreated, asymptomatic, seasonal allergies at the time of dosing), severe adverse drug reaction, or intolerance to artesunate or its derivatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUCinf and AUClast, for DHA | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate. | 1 year |
| Safety laboratory tests, vital signs, and adverse events. | 1 year |
Countries
India
Outcome results
None listed