[Translation] A phase I/IIa clinical study evaluating the safety, tolerability, pharmacokinetics, and dose-response response of fentanyl aerosol (25ug/inhalation) in Chinese patients with cancer burst pain
主要目的:
(1) 初步评估芬太尼气溶胶治疗癌性爆发痛的剂量反应,确定有效剂量范围。
(2) 评估吸入芬太尼气溶胶(25ug/吸)在肿瘤疼痛患者体内的药代动力学(Pharmacokinetics,PK)行为。
次要目的:
(1) 评估肿瘤患者吸入芬太尼气溶胶的安全性,耐受性。
(2) 验证Staccato®设备的基本性能稳定性、可靠性和安全性(包括:药物激发成功率、指纹识别率、电子锁功能是否正常)。
探索性目的:
建立PK-PD模型,探索性评估芬太尼气溶胶在治疗癌性爆发痛的PK/PD关系。
[Translation] main purpose:
(1) Preliminarily evaluate the dose-response of fentanyl aerosol in the treatment of cancerous burst pain, and determine the effective dose range.
(2) To evaluate the pharmacokinetics (PK) behavior of inhaled fentanyl aerosol (25ug/inhalation) in patients with tumor pain.
Secondary purpose:
(1) To evaluate the safety and tolerability of inhaled fentanyl aerosol in tumor patients.
(2) Verify the basic performance stability, reliability and security of the Staccato® device (including: success rate of drug excitation, fingerprint recognition rate, and whether the electronic lock function is normal).
Exploratory Purpose:
A PK-PD model was established to explore the PK/PD relationship of fentanyl aerosol in the treatment of cancerous burst pain.