NCT02713893已完成1 期
A Phase I Study of a Novel Intravaginal Antimycotic Cream (Econazole Nitrate 1% Plus Benzydamine HCl 0.12%) Administered Once Daily for 15 Days to Healthy Women
Aziende Chimiche Riunite Angelini Francesco S.p.A1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Local Adverse Events (AEs)
研究概览
简要总结
The primary objective of the study is to evaluate local tolerability of the new Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and repeated applications once a day for 15 days, safety of the investigational products and comfort of use will also be evaluated as secondary objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Informed consent: signed written informed consent before inclusion in the study;
- •Sex and age: females, aged 18-55 years old inclusive;
- •Body Mass Index (BMI): 18.5-30 kg/m2 inclusive;
- •Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest (sitting position);
- •Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study;
- •Sexual abstinence: agreement to sexual abstinence during the study;
- •Contraception and fertility: women of child-bearing potential, even if sexual abstinent during the study as required by the study inclusion criteria, must be using at least one reliable method of contraception, as follows:
- •hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit;
- •a non-hormonal intrauterine device [IUD] for at least 2 months before the screening visit;
- •a male sexual partner who agrees to use a male condom;
- •a vasectomised sexual partner. Female participants of non-child-bearing potential will be admitted. For all female subjects, pregnancy test result must be negative at screening and at each scheduled evaluation;
- •PAP test: negative result at PAP test (i.e. normal PAP test result without atypical cells) at screening.
排除标准
- •ECG (12-leads, supine position): clinically significant abnormalities;
- •Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study as judged by the investigator;
- •Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness;
- •Allergy: ascertained or presumptive hypersensitivity (including allergies) to the active ingredients (econazole and/ or benzydamine) and/or formulations' excipients or related drugs, e.g. other azoles; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study;
- •Diseases: relevant history of renal, hepatic, gastrointestinal, genitourinary, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study or affect the subject's safety;
- •Genitourinary disease: presence of any specific genitourinary symptoms detected at Visit 2 with the relevant questionnaire (genitourinary symptoms questionnaire);
- •Infection history: history of bacterial urinary tract or bacterial and fungal vaginal infections for 3 weeks before the screening visit;
- •Infections: bacterial or fungal infections (microbiology assessment);
- •Gynaecological findings: clinically significant abnormal findings at the gynaecological visit performed by the study gynaecologist;
- •Mucosa conditions: altered mucosa conditions affecting the site of application (e.g. open lesion or other);
- •Vaginal conditions: use of vaginal detergents, soaps and washes that, in the investigator's opinion, may have an influence on vaginal pH and/or change the vaginal flora;
- •Medications: any medication (topical or systemic), including over the counter, herbal medication, topical drugs on the application area and anticoagulants, such as warfarin and acenocoumarol, for 2 weeks before the start of the study. Hormonal contraceptives and hormonal replacement therapies are allowed. Paracetamol will be allowed as a counter-measure for adverse events, on a case by case basis, if deemed appropriate by the investigator;
- •Investigative drug studies: participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of a previous study and the first day of the present study (date of the informed consent signature);
- •Blood donation: blood donations for 3 months before this study;
- •Drug, alcohol, caffeine, tobacco: history of drug, alcohol (> 1 drink/day, defined according to USDA Dietary Guidelines 2010), tobacco (≥ 10 cigarettes/day) or caffeine (> 5 cups coffee/tea/day) abuse;
- •Diet: Abnormal diets (< 1600 or > 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- •Pregnancy: positive or missing pregnancy test at screening or day 1, pregnant or lactating women or females of child-bearing potential not following adequate contraceptive procedures;
- •Non-compliance: subjects suspected to have a high potential for non-compliance to the study procedures according to the investigator's judgement, including non-compliance to sexual abstinence during the study;
- •Drug test (cocaine, amphetamine, methamphetamine, cannabinoids, opiates and ecstasy): positive result at the drug test at screening
- •Alcohol test: positive alcohol breath test at day 1
研究组 & 干预措施
Placebo
Placebo Comparator
5 grams of Placebo intravaginal cream, once daily for 15 consecutive days.
干预措施: Placebo intravaginal cream (Drug)
Placebo plus Econazole nitrate 1%
Active Comparator
5 grams of Placebo plus Econazole nitrate 1% intravaginal cream, once daily for 15 consecutive days
干预措施: Placebo plus Econazole nitrate 1% intravaginal cream (Drug)
Placebo plus Benzydamine HCl 0.12%
Active Comparator
5 grams of Placebo plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days.
干预措施: Placebo plus Benzydamine HCl 0.12% intravaginal cream (Drug)
Econazole nitrate 1% plus Benzydamine HCl 0.12%
Experimental
5 grams of Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days
干预措施: Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream (Drug)
结局指标
主要结局
Local Adverse Events (AEs)
时间窗: Up to 7 days after administration
Occurrence of local Adverse Events (AEs) reported in the subject's diary as 1-3 scores for pruritus, burning sensation, pain, stinging, dryness; occurrence of all the other local AEs referred by the subject; occurrence of all the local Adverse Drug Reactions (ADRs) revealed by the Investigator
次要结局
- Area under the plasma concentration versus time curve [AUC(0-t)] of econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base)(At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1)
- Change from screening in vaginal pH measurement(From screening (from day -21 to day -7), before the application on days 1, 2, 15, on days 6±1, 9±1, 12±1 at final visit (from day 17 to day 20))
- Treatment Emergent Adverse Events (TEAEs)(15-16 days)
- Change from screening in laboratory parameters(From screening (from day -21 to day -7) and at final visit (from day 17 to day 20))
- Questionnaire for the comfort of use(At final visit (from day 17 to day 20))
- Change from screening in vital signs(From screening (from day -21 to day -7) at days 1 and 15 at pre-dose (0), 12 and 24 hours post-dose)
- Econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base) plasma concentrations(At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1)
- Change from screening in 12-leads ECG(From screening (from day -21 to day -7) at final visit (from day 17 to day 20))
- Change from screening in gynaecological examination findings(From screening (from day -21 to day -7) at final visit (from day 17 to day 20))
- Overall tolerability assessment scale(At final visit (from day 17 to day 20))
研究者
研究点 (1)
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