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MechanismOpioid receptors agonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date07 Aug 1990 |
一项在中国癌性爆发痛患者中评估芬太尼气溶胶(25ug/吸)的安全性和有效性的Ⅱa期临床研究
[Translation] A phase IIa clinical study evaluating the safety and efficacy of fentanyl aerosol (25ug/puff) in Chinese patients with cancer breakthrough pain
主要目的:
初步评估芬太尼气溶胶治疗癌性爆发痛的剂量疗效反应,确定有效剂量范围。
次要目的:
(1) 评估芬太尼气溶胶的安全性。
(2) 验证芬太尼气溶胶吸入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)。
[Translation] Main purpose:
To preliminarily evaluate the dose-effect response of fentanyl aerosol in the treatment of cancer breakthrough pain and determine the effective dose range.
Secondary purpose:
(1) To evaluate the safety of fentanyl aerosol.
(2) To verify the basic performance stability, reliability and safety of fentanyl aerosol inhalation equipment (including: drug stimulation success rate, fingerprint recognition rate, and whether the electronic lock function is normal).
一项在中国癌性爆发痛患者中评估芬太尼气溶胶(25ug/吸)的安全性、耐受性和药代动力学、剂量效应反应的Ⅰ/Ⅱa期临床研究
[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.
100 Clinical Results associated with Beijing Kenuo Medical Technology Co., Ltd.
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100 Translational Medicine associated with Beijing Kenuo Medical Technology Co., Ltd.