A Study to Evaluate the Relative Bioavailability of Two Metronidazole Vaginal Gel Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
研究概览
简要总结
The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female subjects.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females, 18 years of age or older.
- •Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- •Signed informed consent form, which meets all criteria of current FDA regulations.
- •If female and of child bearing potential prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g. condom, IUD, oral or implanted hormonal contraceptives).
- •Weight within + 25% from normal for height and weight for body frame as described in Novum Standard Operating Procedures adapted from the "MetLife® Height and Weight Tablets", Copyright© 1993.
排除标准
- •Females who are pregnant, lactating, or likely to become pregnant during the study.
- •History of allergy or sensitivity to metronidazole, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- •Significant history or current evidence of chronic infectious disease, system disorder or organ disorder.
- •History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
- •Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives or hormonal replacement therapy).
- •Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
- •Receipt of any drug as part of a research study within 30 days prior to dosing.
- •Drug or alcohol addiction requiring treatment in the past 12 months.
- •Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing.
- •Positive test for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
- •Positive test results for drugs of abuse at screening.
- •Evidence of vulvovaginitis or cervicitis (e.g. Bacterial vaginosis, vaginal candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, or history of Herpes simplex or human papillomavirus).
- •Vulvar or vaginal conditions that may affect absorption of the drug.
- •Clinically significant abnormal findings on PAP smear within previous 12 months.
研究组 & 干预措施
1
Metronidazole Vaginal Gel
干预措施: Metronidazole (Drug)
2
MetroGel-Vaginal®
干预措施: Metronidazole (Drug)
结局指标
主要结局
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
时间窗: Blood samples collected over a 60 hour period.
Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
时间窗: Blood samples collected over a 60 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
时间窗: Blood samples collected over a 60 hour period.
Bioequivalence based on AUC0-inf.
次要结局
未报告次要终点