Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5825489 | Clinical Therapeutics | 2012 | 9 Pages |
Abstract
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.
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Authors
Yan-Mei MD, Kanyin E. PhD, Yun MD, Hai-Chen MD, Yun-Xiao MD, Hua-Hua MD, Chuan BS, Gang-Yi MS, Jing-Ying MS, Qing-Si MS, Jian-Min MD, Chen MS,