EUCTR2013-000260-28-GB进行中（未招募）不适用
A single centre, open label, randomised, crossover study in dexamethasone-suppressed healthy adult male volunteers to compare the pharmacokinetics of Infacort® versus immediate-release hydrocortisone tablets at a single dose of 10mg and to evaluate the dose proportionality of Infacort® at doses of 0.5mg, 2mg, 5mg and 10mg. - Infacort®: a new formulation of immediate release hydrocortisone.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Diurnal Ltd
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
- •Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m)2.
- •Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days prior to the first dose.
- •Subjects with a negative urinary drugs of abuse screen, determined within 14 days prior to the first dose.
- •Subjects with negative HIV and Hepatitis B and C results.
- •Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to the first dose.
- •Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
- •Subjects and sexual partners must use effective contraception methods during the trial and for 3 months after the last dose, for example:
- •Oral contraceptive + condom
- •Intra-uterine device (IUD) + condom
- •Diaphragm with spermicide + condom
- •Subjects must be available to complete the study.
- •Subjects must satisfy a medical examiner about their fitness to participate in the study.
- •Subjects must provide written informed consent to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- •Receipt of regular medication within 14 days prior to the first dose (including high dose vitamins, dietary supplements or herbal remedies).
- •Receipt of any vaccination within 14 days prior to the first dose.
- •Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- •Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections)
- •Current or previous history of tuberculosis
- •A clinically significant history of previous allergy / sensitivity to Hydrocortisone and/or Dexamethasone.
- •A clinically significant history or family history of psychiatric disorders/illnesses.
- •A clinically significant history of drug or alcohol abuse.
- •Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- •Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks. (N.B. The washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study)
- •Subjects who have consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or have consumed any alcohol within the 48 hour period prior to the first dose.
- •Donation of 450ml or more of blood within the previous 12 weeks.
- •Subjects who smoke (or ex-smokers who have smoked within 6 months prior to first dose).
- •Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).
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