NCT02720783已完成1 期
A Phase I Study of a Novel Antimycotic Vaginal Pessary Formulation (Econazole Nitrate 150 mg + Benzydamine HCl 6 mg) Administered Once Daily for 3 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 49 人开始时间: 2016年3月4日最近更新:
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
- 49
- 试验地点
- 1
- 主要终点
- Local Adverse Drug Reactions (ADRs)
研究概览
简要总结
The primary objective of the study is to evaluate the local tolerability of the new Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and multiple applications o.d. for 3 days, overall local and general tolerability, safety and comfort of use will also be evaluated.
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: healthy women, 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 sexually 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 on day
- •PAP test: negative PAP test result (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.
- •Allergies: ascertained or presumptive hypersensitivity (including allergies) to the active ingredients (econazole nitrate and/or benzydamine HCl) 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 diseases: 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 or fungal vaginal infections for 3 weeks before the screening visit.
- •Systemic and/or local infections: bacterial or fungal infections that may interfere with the aim of the study or affect the subject's safety. If the results of the microbiological analyses concerning Ureaplasma/Mycoplasma and Actinomyces are positive, the subject can be enrolled only if asymptomatic and without any clinical evidence (gynaecological visit, PAP test and vaginal pH measurement) of vaginal infections.
- •Gynaecological findings: clinically significant abnormal findings at the gynaecological visit performed by the study Gynaecologist.
- •Mucosa conditions: altered mucosa conditions affecting the site of insertion (e.g. open lesions or other).
- •Habits: 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, acenocoumarol and rivaroxaban, 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
Econazole nitrate 150 mg plus Benzydamine HCl 6 mg
Experimental
One vaginal pessary (2.7 g) of Econazole nitrate 150 mg plus Benzydamine HCl 6 mg, once daily, for 3 consecutive days
干预措施: Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary (Drug)
Placebo plus Econazole nitrate 150 mg
Active Comparator
One vaginal pessary (2,7 g) of Placebo plus Econazole nitrate 150 mg, once daily, for 3 consecutive days
干预措施: Placebo plus Econazole nitrate 150 mg vaginal pessary (Drug)
Placebo plus Benzydamine HCl 6 mg
Active Comparator
One vaginal pessary (2,7 g) of Placebo plus Benzydamine HCl 6 mg, once daily, for 3 consecutive days
干预措施: Placebo plus Benzydamine HCl 6 mg vaginal pessary (Drug)
Placebo
Placebo Comparator
One vaginal pessary (2.7 g) of Placebo, once daily, for 3 consecutive days
干预措施: Placebo vaginal pessary (Drug)
结局指标
主要结局
Local Adverse Drug Reactions (ADRs)
时间窗: Up to 7 days after administration
Occurence of local ADRs reported by the subjects as 1-3 scores for pruritus, burning sensation, pain, stinging and dryness; occurrence of all the other local Adverse Events (AEs) referred by the subjects; occurrence of all the local ADRs revealed by the Investigator/ Gynaecologist
次要结局
- Questionnaire for the comfort of use(At final visit (from day 5 to day 8))
- 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 (day 1) and the last dose (day 3))
- 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 (day 1) and the last dose (day 3))
- Overall local tolerability assessment scale(At final visit (from day 5 to day 8))
- Change from screening in laboratory parameters(From screening (from day -21 to day -7) at final visit (from day 5 to day 8))
- Occurrence of all AEs and ADRs(5-8 days)
研究者
研究点 (1)
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