A Phase I, Multiple dose, Placebo controlled parallel group double blind study to evaluate the safety and tolerability of Spironolactone 5% topical cream in Healthy adult male subject.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary endpoint: To compare safety of Spironolactone 5% topical cream versus placebo
研究概览
简要总结
A Phase I, Multiple dose, placebo controlled parallel group randomised double blind study to evaluate the safety and tolerability of Spironolactone 5% topical cream in Healthy adult male subject. Hormonal changes of serum testosterone and serum dihydrotestosterone in healthy adult male subject will also be evaluated. The study will be conducted in 30 subjects (i.e. 15 subjects per treatment arm). The study duration will be approx 16 days from the day of check-in during which subjects shall receive a dose of 1 gm of either the test formulation Spironolactone 5% topical cream or placebo formulation on ventral aspect of forearm (approx 16 cm2 of the body surface area) twice daily at an interval of 12 hours (±05 minutes) for 14 consecutive days (i.e. Day 01 to Day 14) under the supervision of trained study personnel. The site of application will be assessed by Skin Irritation Score additionally vital signs, clinical examination and general well being shall also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •BMI: 18.5 to 30.0 kg/m2, both inclusive. 2) Able to give written informed consent to participate in the study. 3) Non-smokers and non-tobacco users (i.e. having no history of smoking and tobacco consumption for at least one year prior to study) 4) All volunteers must be judged by the principal or sub-investigator as normal and healthy during a pre-study safety assessment performed within 14 days of the first dose of cream application which will include: a) A physical examination with no clinically significant finding. b) Results within normal limits or clinically non-significant for the laboratory tests.
- •Additional tests and/or examinations may be performed, if necessary, based on Principal Investigator discretion.
- •All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
排除标准
- •Volunteers must not be enrolled in the study if they meet any one of the following criteria: 1) History of allergic responses to Spironolactone or other related drugs, or any of its formulation ingredients.
- •Volunteer has tattoo, mark of injury/surgery, any discolouration of skin, any other birth mark on application area of skin, any ongoing skin disease or history of frequent skin disease, damaged skin at application sites or has cracks/hardening/scarring at the application site 3) Volunteer has excessive hair at the application site 4) Presence of open sores, or other skin abnormalities at the application site 5) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG and chest X-ray recording].
- •Use of enzyme-modifying drugs [i.e. strong CYP3A inhibitors such as boceprevir, cobicistat, conivaptan, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, telaprevir, tipranavir and ritonavir, troleandomycin, voriconazole and strong CYP3A inducers such as carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort etc.] within 30 days prior to the first dose of cream application.
- •History or evidence of drug dependence or of alcoholism.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •Volunteers who have received a known Investigational drug within ten elimination half life of the administered drug or within 30 days prior to cream application, whichever is greater.
- •Use of Topical analgesic or antihistaminic cream within 14 days prior to first dose of cream application.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the volunteer’s participation in this study.
- •Institutionalized volunteer (having no association with Cliantha Research Limited, i.e. Employee).
- •Use of medicine [prescribed and over the counter (OTC) medication including herbal remedies] at any time within 14 days prior to first dose of cream application.
- •Found positive in urine test for drugs of abuse and/or alcohol breath test done before check-in.
- •Consumption of grapefruit or grape fruit products within 7 days prior to the first dose of cream application.
结局指标
主要结局
Primary endpoint: To compare safety of Spironolactone 5% topical cream versus placebo
时间窗: daily upto 14 days
Secondary Endpoint: To compare serum testosterone & serum dihydrotestesterone level of Spironolactone 5% topical cream with placebo
时间窗: daily upto 14 days
次要结局
- Secondary Endpoint: To compare serum testosterone & serum dihydrotestesterone level of Spironolactone 5% topical cream with placebo(At baseline and at day 15)