An Open-label, Randomised, Multiple-dose, Three-period Crossover Study in Healthy Male and Female Volunteers to Characterise Pharmacokinetics and Assess the Relative Bioavailability of Two New Oral Formulations of Ambroxol Hydrochloride as Lasolvan® Prolonged-release Hard Capsules 75 mg and Lasolvan® Effervescent Tablets 60 mg Compared to Lasolvan® Tablets 30 mg.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State
研究概览
简要总结
To characterise pharmacokinetics and assess the relative bioavailability of two new oral formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg
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 45 Years（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
Treatment sequence 5
Reference product, Washout 6 days, Treatment 1, Washout 6 days, Treatment 2
干预措施: Lasolvan tablet (Drug)
Treatment sequence 1
Treatment 1, Washout 6 days, Reference product, Washout 6 days, Treatment 2
干预措施: Lasolvan tablet (Drug)
Treatment sequence 1
Treatment 1, Washout 6 days, Reference product, Washout 6 days, Treatment 2
干预措施: Lasolvan prolonged-released capsules (Drug)
Treatment sequence 1
Treatment 1, Washout 6 days, Reference product, Washout 6 days, Treatment 2
干预措施: Lasolvan effervescent tablet (Drug)
Treatment sequence 2
Treatment 2, Washout period 6 days, Treatment 1, Washout 6 days, Reference product
干预措施: Lasolvan tablet (Drug)
Treatment sequence 2
Treatment 2, Washout period 6 days, Treatment 1, Washout 6 days, Reference product
干预措施: Lasolvan effervescent tablet (Drug)
Treatment sequence 2
Treatment 2, Washout period 6 days, Treatment 1, Washout 6 days, Reference product
干预措施: Lasolvan prolonged-release hard capsule (Drug)
Treatment sequence 3
Reference product, Washout 6 days, Treatment 2, Washout 6 days, Treatment 1
干预措施: Lasolvan effervescent tablet (Drug)
Treatment sequence 3
Reference product, Washout 6 days, Treatment 2, Washout 6 days, Treatment 1
干预措施: Lasolvan tablet (Drug)
Treatment sequence 3
Reference product, Washout 6 days, Treatment 2, Washout 6 days, Treatment 1
干预措施: Lasolvan prolonged-release hard capsule (Drug)
Treatment Sequence 4
Treatment 2, Washout 6 days, Reference product, Washout 6 days, Treatment 1
干预措施: Lasolvan tablet (Drug)
Treatment Sequence 4
Treatment 2, Washout 6 days, Reference product, Washout 6 days, Treatment 1
干预措施: Lasolvan effervescent tablet (Drug)
Treatment Sequence 4
Treatment 2, Washout 6 days, Reference product, Washout 6 days, Treatment 1
干预措施: Lasolvan prolonged-release hard capsule (Drug)
Treatment sequence 5
Reference product, Washout 6 days, Treatment 1, Washout 6 days, Treatment 2
干预措施: Lasolvan prolonged-release hard capsule (Drug)
Treatment sequence 5
Reference product, Washout 6 days, Treatment 1, Washout 6 days, Treatment 2
干预措施: Lasolvan effervescent tablet (Drug)
Treatment Sequence 6
Treatment 1, Washout 6 days, Treatment 2, Washout 6 days, Reference product
干预措施: Lasolvan tablet (Drug)
Treatment Sequence 6
Treatment 1, Washout 6 days, Treatment 2, Washout 6 days, Reference product
干预措施: Lasolvan effervescent tablet (Drug)
Treatment Sequence 6
Treatment 1, Washout 6 days, Treatment 2, Washout 6 days, Reference product
干预措施: Lasolvan prolonged-release hard capsule (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State
时间窗: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24)
Maximum Measured Concentration of the Analyte in Plasma at Steady State
时间窗: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Maximum measured concentration of the analyte in plasma at steady state (Cmax ss)
次要结局
- Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State(Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg)
- Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg(Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg)
- Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)(Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg)
- Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval(Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg)
- Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma(Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg)
- Peak-trough Swing(Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg)
- Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State(Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg)
- Time Period When Concentration of the Analyte Exceeds Cav ss(Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg)
- Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss(Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg)