临床试验/NCT01984086

NCT01984086已完成1 期

An Open-label, Randomised, Cross-over, Two Cohort, Single Dose Study in Healthy Volunteers to Evaluate the Unit Dose Dry Powder Inhaler (UD-DPI) for the Delivery of Salbutamol and to Compare the Pharmacokinetic Profile With the MDI and Diskus Presentations.

GlaxoSmithKline1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2013年10月21日最近更新: 2018年6月19日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 60
试验地点: 1
主要终点: Part A: Pharmacokinetics parameters of single doses of salbutamol in healthy subjects delivered via the UD-DPI device, using a range of doses and blends, and to compare to MDI and Diskus

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open-label, two part, six period- cross over, randomised, single dose, single centre study in healthy subjects. This is the first clinical study for the UD-DPI. This study is divided into two parts. Part A will ascertain whether the pharmacokinetic (PK) of salbutamol delivered via the UD-DPI is comparable to the salbutamol delivered via the Diskus or MDI. For this reason four treatment doses consisting of three dose strength and two percentage blends will be assessed in Part A delivered via UD-DPI. Part A will also provide preliminary PK variability estimates to allow for better sample size/precision calculations for Part B. Part B will explore whether the UD-DPI has a pharmacokinetic exposure profile that is comparable to either Diskus or MDI in the presence of the charcoal block.

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 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Part A

Experimental

Subjects will receive following six treatments each in six period, with a 3-days minimum wash-out period, between each treatment period: 1) Single dose (SD) salbutamol (200mcg per blister from 1.6% blend) delivered via the UD-DPI by inhalation of 3 Blisters (BTR) giving a total dose of 600mcg; 2) SD salbutamol sulphate (200mcg per BTR from a 1.0% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 600mcg; 3) SD salbutamol (150mcg per BTR from a 1.6% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 450mcg; 4) SD salbutamol (250mcg per BTR from a 1.6% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 750mcg; 5) SD of salbutamol (200mcg per BTR) delivered via the Diskus by inhalation of 3 BTR giving a total dose of 600mcg; 6) SD salbutamol (100mcg per actuation) delivered via the MDI giving a total dose of 600mcg

干预措施: Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend) (Drug)

Part A

Experimental

干预措施: Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend) (Drug)

Part A

Experimental

干预措施: Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend) (Drug)

Part A

Experimental

干预措施: Salbutamol Sulphate 200mcg UD-DPI Blister(1% blend) (Drug)

Part A

Experimental

干预措施: Salbutamol Diskus 200mcg Blister (Drug)

Part A

Experimental

干预措施: Salbutamol MDI 100mcg (Drug)

Part B

Experimental

Prior to the start of Part B, a decision will be made regarding the UD-DPI products to be used in Part B. Subjects will receive following 6 treatments each in 6 period, with a 3-days minimum wash-out period, between each treatment period: 1) SD salbutamol (selected from Part A) delivered via the UD-DPI without activated charcoal (AC) by inhalation of 3 BTR (total dose dependant on UD-DPI formulation chosen); 2) SD salbutamol (selected from Part A) delivered via the UD-DPI with AC by inhalation of 3 BTR (total dose dependant on UD-DPI formulation chosen); 3) SD salbutamol by inhalation of 3 BTR (200mcg per BTR) delivered via the Diskus without AC (total dose 600mcg); 4) SD salbutamol by inhalation of 3 BTR (200mcg per BTR) delivered via the Diskus with AC (total dose 600mcg); 5) SD salbutamol 6 inhalations (100mcg) delivered via the MDI without AC (total dose 600mcg); 6) SD salbutamol 6 inhalations (100mcg) delivered via the MDI with AC (total dose 600mcg)

干预措施: Salbutamol Sulphate UD-DPI Blister (selected from Part A) (Drug)

Part B

Experimental

干预措施: Salbutamol Sulphate 250mcg UD-DPI Blister (selected from Part A) (Drug)

Part B

Experimental

干预措施: Salbutamol Diskus 200mcg Blister without activated charcoal (Drug)

Part B

Experimental

干预措施: Salbutamol Diskus 200mcg Blister with activated charcoal (Drug)

Part B

Experimental

干预措施: Salbutamol MDI 100mcg without activated charcoal (Drug)

Part B

Experimental

干预措施: Salbutamol MDI 100mcg with activated charcoal (Drug)

结局指标

主要结局

Part A: Pharmacokinetics parameters of single doses of salbutamol in healthy subjects delivered via the UD-DPI device, using a range of doses and blends, and to compare to MDI and Diskus

时间窗: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)

PK parameters include: area under the concentration-time curve from time zero (pre-dose) to 12 hours (hr) (AUC \[0-12hr\]) and/ or area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC \[0-infinity\]) and/ or area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC \[0-t\]) and maximum observed concentration (Cmax).

Part B: Pharmacokinetics parameters of salbutamol in healthy subjects delivered via UD-DPI versus Diskus and/or MDI with charcoal blockade.

时间窗: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)

PK parameters include: AUC(0- infinity) or AUC(0-t) and Cmax

次要结局

Part A: Pharmacokinetic parameters following single doses of salbutamol and different blends of salbutamol in healthy subjects delivered via UD-DPI(Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose))
Part A and B: Safety and tolerability of salbutamol, as assessed vital signs(Day 1 of each treatment period)
Part B: Pharmacokinetic parameters following single doses of salbutamol in healthy subjects delivered via UD-DPI , MDI and Diskus with/ and without charcoal(Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose))
Part A and B: Number of subjects with adverse events (AEs)(Up to 14 days after the last dose of study treatment.)
Part A and B: Safety and tolerability of salbutamol, as assessed by 12-lead electrocardiogram (ECG) parameters(Day 1 of each treatment period)

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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