[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 breakthrough 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 objectives:
(1) To preliminarily evaluate the dose response of fentanyl aerosol in the treatment of cancer breakthrough pain and determine the effective dose range.
(2) To evaluate the pharmacokinetic (PK) behavior of inhaled fentanyl aerosol (25ug/inhalation) in patients with tumor pain.
Secondary objectives:
(1) To evaluate the safety and tolerability of inhaled fentanyl aerosol in cancer patients.
(2) To verify the basic performance stability, reliability and safety of the Staccato® device (including: drug stimulation success rate, fingerprint recognition rate, and whether the electronic lock function is normal).
Exploratory objectives:
Establish a PK-PD model to explore the PK/PD relationship of fentanyl aerosol in the treatment of cancer breakthrough pain.