CTRI/2021/04/032482已完成不适用
Single dose two-way crossover bioequivalence pharmacodynamics end point study on Tetracosactide Injection BP 250 mcg/mL in healthy adult human subjects under fasting condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to compare the plasma cortisol (pharmacodynamics marker) concentration response of Test product (T) and Reference product (R), administered as a 1 mL x 250 mcg/mL injection, in healthy, adult, human subjects under fasting conditions.
研究概览
简要总结
A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence, pharmacodynamics (PD) end point study under fasting condition.
The primary objective of this study is to compare the plasma cortisol (pharmacodynamics marker) concentration response of Test product (T) and Reference product (R), administered as a 1 mL x 250 mcg/mL injection, in healthy, adult, human subjects under fasting conditions.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject is in the age range of 18-50 years.
- •2.Subject has voluntarily given written informed consent to participate in this study.
- •3.Subject is healthy as determined by medical history and physical examination performed within 28 days prior to the commencement of the study.
- •4.Subject must have clinically acceptable results for all the screening parameters and laboratory investigations.
- •5.Subject has body mass index (BMI) greater than or equal 18.50 and less than 30.00 kg/m
- •6.Subject has hemoglobin level greater than or equal 12.0 g/dL (Deciliter) for males or greater than or equal 11.0 g/dL for females.
- •7.If subject is female and: a)Of childbearing potential, is practicing or willing to practice an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or b)Is post-menopausal (Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago) or c)Is surgically sterile (Hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months ago).
排除标准
- •1.Subject has history of hypersensitivity to tetracosactide or any other similar class of drugs.
- •2.Subject has history of psychological disturbances (e.g. euphoria, insomnia, mood swings, personality changes and severe depression, or even frank psychotic manifestations) 3.Subject has history of tuberculosis/amoebiasis and/or has any sequelae as a result of these infections in the past.
- •4.Subject has history of drug induced rash and/or pruritus.
- •5.Subject has any evidence of organ dysfunction or any clinically significant abnormality as determined from physical or clinical examinations.
- •6.Subject has history of serious medical illnesses including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease etc., systemic diseases including but not limited to diabetes, hypertension, sarcoidosis, rheumatic diseases & thyroid abnormalities, diseases like immunosuppression, glaucoma and/ or any serious, potentially life-threatening illness.
- •7.Subject has inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide, written informed consent.
- •8.Subject is a regular smoker, who smokes more than 10 cigarettes daily or has difficulty abstaining from smoking for the duration of study period.
- •9.Subject has history of drug dependence or excessive alcohol intake on a habitual basis or has difficulty in abstaining or found positive in urinary alcohol test before admission.
- •10.Subject has used any medication (Including females taking oral contraceptives) within 30 days prior to admission of this study.
- •11.Subject has donated blood (1 unit or 350 mL) or received an investigational medicinal product within 90 days prior to receiving the first dose of study drug.
- •Elimination half-life of the study drug should be taken into consideration for his/ her inclusion in the study.
- •a)Note: If subject had participated in a study at CPU New Delhi in which blood loss was less than or equal to 200 mL, subject may be dosed 60 days after the last pharmacokinetic sample of previous study.
- •12.Subject has consumed alcohol 48 hours prior to admission.
- •13.Subject has consumed grapefruit juice and or grape fruit supplements containing products 48 hours prior to admission.
- •14.If subject is a female volunteer and demonstrating a positive pregnancy test prior to admission.
- •15.If subject is a female volunteer and currently breast-feeding.
结局指标
主要结局
The primary objective of this study is to compare the plasma cortisol (pharmacodynamics marker) concentration response of Test product (T) and Reference product (R), administered as a 1 mL x 250 mcg/mL injection, in healthy, adult, human subjects under fasting conditions.
时间窗: At the end of the study when all 48 Subjects have completed the study
次要结局
- The secondary objective of this study is to monitor the safety of Test product (T) and Reference product (R) in healthy, adult, human subjects under fasting condition.(At the end of the study when all 48 Subjects have completed the study)
研究者
研究点 (1)
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