Randomised Single Dose 3 Way Crossover Single Blind Study to Evaluate the Pharmacokinetic Dose Proportionality, Compare the Bioavailability and Safety of Clonidine Mucoadhesive Buccal Tablets (MBT) With Catapres in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Dose proportionality of two strengths of clonidine MBT (50μg and 100 μg) as assessed by Non-compartmental pharmacokinetic analysis (Area Under the Curve)
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.
详细描述
A single blind, randomised, 3-period, 3-sequence single-dose crossover study to determine the pharmacokinetic dose proportionality of Clonidine MBT 50 μg and Clonidine MBT 100 μg and comparative bioavailability of clonidine from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy male and female subjects.
36 subjects will be randomised for 30 to complete the study. The study will comprise of 3 Treatment Periods (1, 2 and 3) and a post study follow up (7 - 12 days after the last dose). Study drug will be administered on the morning of Day 1. Pharmacokinetic (PK) blood samples will be collected for each of three treatment periods. Safety will be evaluated at specified times throughout the study. There will be at least 7 days between dose administrations.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females (non-pregnant/non-lactating) aged 18 - 50 years.
- •A Body Mass Index (BMI) of 18-
- •No clinically significant abnormal serum biochemistry, haematology and urine examination values.
- •A negative urinary drugs of abuse screen.
- •Negative HIV and Hepatitis B and C results.
- •No clinically significant abnormalities in 12-lead electrocardiogram (ECG).
- •No clinically significant abnormalities in blood pressure or pulse.
- •No allergy or sensitivity to clonidine or any of its excipients.
- •No allergy to milk or milk derivatives.
- •Subjects must provide written informed consent to participate in the study
排除标准
- •Current or past medical condition that might significantly affect the pharmacokinetic or
- •pharmacodynamic response to clonidine.
- •Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days.
- •Pathological condition of the oral cavity that would affect administration via the buccal route.
- •Raynaud's disease or other peripheral vascular disease.
- •Receipt of regular medication within 14 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
- •Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- •Symptomatic postural hypotension evident on screening
- •History or evidence of Suicidal Ideation and/or behaviour as determined by using Columbia-Suicide Severity Rating Scale (C-SSRS)
研究组 & 干预措施
Clonidine MBT 50µg
Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50µg single dose, Clonidine MBT 100μg single dose ,a single-dose of reference catapres 100μg tablets.
干预措施: Clonidine MBT 50µg (Drug)
Clonidine MBT 100µg
Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50μg single dose, Clonidine MBT 100µg single dose ,a single-dose of reference catapres 100μg tablets..
干预措施: Clonidine MBT 100µg (Drug)
Catapres 100μg
Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50μg single dose, Clonidine MBT 100μg single dose ,a single-dose of reference catapres 100μg tablets.
干预措施: Catapres 100μg (Drug)
结局指标
主要结局
Dose proportionality of two strengths of clonidine MBT (50μg and 100 μg) as assessed by Non-compartmental pharmacokinetic analysis (Area Under the Curve)
时间窗: 3 Months
To evaluate dose proportionality of two strengths (50 μg and 100 μg) of Clonidine MBT, by using Area Under the Curve (AUC)
Bioavailability of clonidine from Clonidine MBT 50 μg and 100 μg with that from oral clonidine hydrochloride 100 μg tablets. (Area Under the Curve)
时间窗: 3 Months
To compare the bioavailability of clonidine from Clonidine MBT® 50 μg and 100 μg with that from oral clonidine hydrochloride 100 μg tablets, by using Area Under the Curve (AUC)
次要结局
- General safety information (adverse events, (AEs), 12-lead electrocardiogram (ECG) and vital signs), during the study period.(3 Months)