CTRI/2019/02/017469已完成不适用
Relative Bioavailability Study of Hydrocortisone Acetate 25 mg and 45 mg Suppository in Healthy Adult Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine the bioavailability of hydrocortisone following rectal administration of hydrocortisone acetate 25 mg and 45 mg suppository (test product) relative to the reference products (hydrocortisone acetate 1% and pramoxine hydrochloride 1% topical aerosol foam [Proctofoam®] and hydrocortisone oral tablets)
研究概览
简要总结
Relative Bioavailability Study of Hydrocortisone Acetate 25 mg and 45 mg Suppository in Healthy Adult Volunteers. This is a single-center, randomized, open-label, single-dose, 4-treatment, 4-period, 4-sequence crossover study with a 1-week washout between periods to be conducted in 20 healthy adult volunteers. The primary objective is to determine the bioavailability of hydrocortisone following rectal administration of hydrocortisone acetate 25 mg and 45 mg suppository (test product) relative to the reference products (hydrocortisone acetate 1% and pramoxine hydrochloride 1% topical aerosol foam [Proctofoam® ] and hydrocortisone oral tablets)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy males or females of any race, 18-55 years of age (both inclusive) at screening
- •BMI of 18.5-30.0 kg/m2 (both inclusive)
- •If a woman of child-bearing potential, have a negative serum pregnancy test at screening and a negative urine pregnancy test at check in on Day-
- •From the time of screening until 30 days after the last study dose, subjects must be sexually inactive, sterile, or using effective methods of contraception as follows: If the subject is a male with a female sexual partner who is of childbearing potential, the couple is willing to use two effective methods of birth control during the duration of the trial and for one month after the final evaluation or early termination.
- •A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must agree to use two effective methods of contraception for the duration of the study and at least 1 month after the final evaluation or early termination.
- •The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives with a stable dose for at least 1 month prior to check-in on Day 1; hormonal intra-uterine device (IUD) inserted at least 1 month prior to check-in for Period 1 on Day -1
- •Willing to participate in the study, able to understand and likely to complete all study requirements, and willing to provide voluntary informed consent before initiation of any study-related procedures
- •In the opinion of the Principal Investigator, able to fully comply with the study requirements and judged to be healthy on the basis of the medical history and screening procedures (physical examination, vital signs, and safety laboratory test results)
- •Negative test for selected drugs of abuse at Screening visit and check-in on Day-1
- •Negative test for alcohol breath test at check-in on Day -1
- •Negative hepatitis panel and negative Human Immunodeficiency Virus (HIV) antibody tests.
排除标准
- •Known hypersensitivity to dexamethasone, hydrocortisone, pramoxine, or any of the active or inactive ingredients in the drug treatment
- •Female who is pregnant or lactating, or is planning a pregnancy during the study, or if of child-bearing potential, is unwilling to adhere to the methods of contraception detailed above
- •Any abnormal laboratory value during screening or check-in on Day -1 that, in the opinion of the Principal Investigator, would interfere with the conduct of the study or safety of the subject
- •History or presence of any significant metabolic, allergic, cardiovascular, pulmonary, hepatic, renal, or hematologic (bleeding) disorders
- •History or presence of any significant gastrointestinal disorder (peptic ulcer disease, gastritis or bleeding diathesis, proctitis, colitis, inflammatory bowel disease, lower gastrointestinal bleeding, active hemorrhoids, and history of constipation or diarrhea/frequent bowel movements per day) within 60 days prior to Day -1
- •History or presence of any significant endocrine disorders (including Addison’s Disease, Cushing’s Syndrome, and Cushingoid features)
- •History or presence of any significant immunologic, dermatologic, muscular, neurological, psychiatric, neoplastic, or other disease, which, in the opinion of the Principal Investigator, could interfere with the course of the study or expose the subject to undue risk by participating in this study
- •Currently participating or has participated within 30 days prior to screening in an investigational drug or device study
- •Inability to fully comply with the study protocol
- •Seated (after at least 5 minutes rest in a sitting position) systolic blood pressure >140 mmHg or <90 mmHg or a diastolic blood pressure >95 mmHg during Screening
- •Heart rate at rest of <50 beats per minute (bpm) or >100 bpm during Screening 12.Subjects who have a history of any of the following will be excluded: a.
- •Allergy to dexamethasone, hydrocortisone, pramoxine, or to any ingredient in the test drugs b.
- •HIV, hepatitis, or other blood-borne pathogens c.
- •Liver damage or renal impairment
- •Prior or current rectal corticosteroid treatment within 6 months of screening and treatment
- •Use of any prescription medications/products, or over-the-counter(OTC)/non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within the 14 days prior to Day -1, or 5 half-lives, whichever is longer, unless deemed acceptable by the Principal Investigator in consultation with the Sponsor Medical Monitor
- •Any significant rectal pathology that, in the opinion of the Principal Investigator or designee, would be a contraindication (or warning) with a hydrocortisone acetate suppository, including rectal obstruction, abscess, perforation, active fungal infection(s) and/or bacterial infection(s)
- •Anal or rectal surgery within the previous 2 years
- •Use of anorectal medications, including creams, ointments, suppositories, foams, and enemas or insertion of any medication or object into the rectum from the time of screening through the end of study
- •Receipt of blood products within 2 months prior to Day -1
- •Consumption of alcohol-containing foods or beverages within the 60 hours prior to Day-1 and throughout the study and the consumption of caffeine-containing foods or beverages within the 12 hours prior to Day-1 and throughout the remainder of the study
- •In the Principal Investigator’s opinion, have been on an abnormal diet (for whatever reason) during the 28 days prior to Day -1.
结局指标
主要结局
To determine the bioavailability of hydrocortisone following rectal administration of hydrocortisone acetate 25 mg and 45 mg suppository (test product) relative to the reference products (hydrocortisone acetate 1% and pramoxine hydrochloride 1% topical aerosol foam [Proctofoam®] and hydrocortisone oral tablets)
时间窗: Blood samples will be collected on Days 1, 8, 15, and 22; at -0.50, -0.25, and 0 (immediately prior to dosing) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, and 24 hours post-dose
次要结局
- To evaluate the safety and tolerability of a single rectal administration of hydrocortisone acetate suppository(Days 1, 8, 15, and 22)
研究者
研究点 (1)
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