An Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Derived pharmacokinetic parameter: Tmax
研究概览
简要总结
This was an open label, randomized, single dose, three period crossover pharmacokinetic study of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups (Group 1, n=18 and Group 2, n=12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
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-
- •Body Mass Index = Body weight (kg) / (Height (m))
- •Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the start of the study. The parameters measured included those shown in Appendix 3 of the Study Protocol.
- •Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study.
- •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 of the start of the study.
- •Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
- •Subjects and sexual partners must have used 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 spermacide + condom
- •Subjects must have been available to complete the study.
- •Subjects must have satisfied a medical examiner about their fitness to participate in the study.
- •Subjects must have provided written informed consent to participate in the study.
排除标准
- •A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- •Receipt of regular medication within 14 days of the first study day (including high dose vitamins, dietary supplements or herbal remedies).
- •Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- •A clinically significant history of previous allergy / sensitivity to Hydrocortisone.
- •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.
- •Subjects who had consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or had consumed any alcohol within the 48 hour period prior to the first dose.
- •Donation of 450ml or more blood within the previous 12 weeks.
- •Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).
研究组 & 干预措施
Group 1
Volunteers in group 1 received the following interventions:
Chronocort® 30 mg given at night (~ 23:00h) as a combination of one 10mg capsule and one 20mg capsule (n=18).
Chronocort® 30mg given as one 20mg capsule at night (~ 23:00h) and as one 10mg capsule in the morning (~ 7:00h) following the initial night-time dose (n=18).
Hydrocortisone 30mg given at night (~ 23:00h) given as three 10mg tablets (n=18).
Each administration of IMP was separated by a washout period of at least 7 days.
干预措施: Chronocort (Drug)
Group 1
Volunteers in group 1 received the following interventions:
Chronocort® 30 mg given at night (~ 23:00h) as a combination of one 10mg capsule and one 20mg capsule (n=18).
Chronocort® 30mg given as one 20mg capsule at night (~ 23:00h) and as one 10mg capsule in the morning (~ 7:00h) following the initial night-time dose (n=18).
Hydrocortisone 30mg given at night (~ 23:00h) given as three 10mg tablets (n=18).
Each administration of IMP was separated by a washout period of at least 7 days.
干预措施: Hydrocortisone (Drug)
Group 2
Volunteers in group 2 received the following interventions:
Chronocort® 5mg given at night (~ 23:00h) as one 5mg capsule (n=12).
Chronocort® 10mg given at night (~ 23:00h) as one 10mg capsule (n=12).
Chronocort® 20mg given at night (~ 23:00h) as one 20mg capsule (n=12).
Each administration of IMP was separated by a washout period of at least 7 days.
干预措施: Chronocort (Drug)
结局指标
主要结局
Derived pharmacokinetic parameter: Tmax
时间窗: 24 hours
Tmax measures the time at which Cmax - maximum serum concentration - is observed
Derived pharmacokinetic parameter: AUC(0-∞)(Area under the curve)
时间窗: 24 hours
Area under the serum concentration versus time curve from time = 0h extrapolated to infinity
Derived pharmacokinetic parameter: Cmax
时间窗: 24 hours
Cmax measures the time taken for the drug/metabolite to reach maximum serum concentration
Derived pharmacokinetic parameter: CL
时间窗: 24 hours
Time to drug clearance
Derived pharmacokinetic parameter: T1/2
时间窗: 24 hours
Time required to reach 1/2 Cmax
Derived pharmacokinetic parameter: Tlag
时间窗: 24 hours
Tlag measures the delay between dosing and being able to observe the drug/metabolite within the sampling area (e.g., blood serum)
Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve)
时间窗: 24 hours
Area under the serum concentration versus time curve from time
次要结局
未报告次要终点