Pharmacokinetic Properties and Bioequivalence of Two Sulfadoxine/Pyrimethamine Fixed-Dose Combination Tablets: A Parallel-Design Study in Healthy Chinese Male Volunteers

The findings from this single-dose (1500/75-mg) study suggest that the test and reference formulations of sulfadoxine/pyrimethamine FDC 500/25-mg tablet have similar pharmacokinetic profiles both in terms of rate and extent of absorption. The formulations met WHO's and China's FDA regulatory criteria for bioequivalence in these healthy Chinese volunteers under fasting conditions. Both formulations were generally well-tolerated.