ISRCTN15152571已完成1 期
A phase I, single-centre, open study to assess the pharmacokinetic profile and safety of a 100 mg Clindamycin Hydrochloride Vaginal Insert (CHVI) in healthy females
Controlled Therapeutics (Scotland) Ltd (UK)0 个研究点目标入组 10 人开始时间: 2007年10月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Healthy female volunteers aged between 18 - 50 years
- •2. Urine negative for a urinary tract infection
- •3. Up to date with regular pap smear tests in accordance with local health authority guidelines
- •4. Agree to refrain from placing anything on the following list in their vagina other than the study drug from the day of admission to the clinical trial unit until completion of the follow-up visit:
- •4.1. Use of feminine deodorant sprays/products, spermicides*, douches, condoms*, tampons, diaphragms* or any other pharmaceutical or over the counter vaginal product
- •Barrier methods of contraception as indicated above (*) may be resumed following discharge from the clinic (Day 3)
- •4.2. Vaginal intercourse is permitted except for the 24-hour period prior to admission and during the residential period of the study
- •5. Written informed consent
排除标准
- •1. Volunteers expected to menstruate from Day 0 to Day 6 or during the 48 hours prior to dosing
- •2. Volunteers who have a vaginal pH of 4.7 or higher and have any other signs or symptoms of infections at screening and prior to Dosing Day 1
- •3. Volunteers who have any significant history of drug allergies especially to clindamycin or lincomycin
- •4. Urinary tract infection in the previous 6 months or have a significant history of recurring urinary tract infections
- •5. Antimicrobial and/or antifungal therapy (systemic or intravaginal) within 14 days of dosing
- •6. Signs and/or symptoms of vaginal infection or infections within the last month or positive vaginal swab culture (to definite specific pathogens) at screening
- •7. Known current Sexually Transmitted Infection (STI) to be established by discussion
- •8. Contraindications for clindamycin per current labelling of marketed intravaginal formulations
- •9. Diagnosis or treatment in the previous 6 months for Cervical Intra-epithelial Neoplasia (CIN) or cervical carcinoma
研究者
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