Lack of a Pharmacokinetic Interaction Between SYM-1219 Granules Containing 2 Grams of Secnidazole and a Combined Oral Contraceptive in a Phase 1, Randomized, Open-Label Study in Healthy Female Volunteers
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- 作者：Helen S. Pentikis ; Nikki Adetoro ; Carol J. Braun
- 关键词：Bacterial vaginosis ; Clinical trial ; Infectious diseases ; Oral contraceptives ; Pharmacokinetics ; Secnidazole
- 刊名：Advances in Therapy
- 出版年：2017
- 出版时间：January 2017
- 年：2017
- 卷：33
- 期：12
- 页码：2229-2241
- 全文大小：
- 刊物主题：Internal Medicine; Oncology; Cardiology; Rheumatology; Endocrinology; Pharmacology/Toxicology;
- 出版者：Springer Healthcare
- ISSN：1865-8652
- 卷排序：33
文摘
IntroductionBacterial vaginosis (BV) is a serious infection that is the most common vaginal infection in women of childbearing potential. SYM-1219 is a novel, granule formulation containing 2 g of secnidazole that is being developed as a single, oral dose to treat women with BV. Because many of the women diagnosed with BV use hormonal contraception, the effect of SYM-1219 on the pharmacokinetics (PK) of commonly prescribed oral contraceptive drugs, ethinyl estradiol (EE2), and norethindrone (NET) was evaluated.