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评价MT-1207缓释片在健康受试者和轻、中度高血压患者中耐受性、药代动力学的随机、双盲、安慰剂对照的I期临床试验
[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial evaluating the tolerability and pharmacokinetics of MT-1207 extended-release tablets in healthy subjects and patients with mild to moderate hypertension.
Part A:
主要研究目的:
评价MT-1207缓释片在健康受试者中单次、多次给药剂量递增的药代动力学。
次要研究目的:
评价MT-1207缓释片在健康受试者中单次、多次给药剂量递增的安全性和耐受性;
评价食物对MT-1207缓释片在健康受试者体内的药代动力学的影响。
Part B:
主要研究目的:
评价MT-1207缓释片在轻、中度高血压患者中多次给药的安全性、耐受性。
次要研究目的:
评价MT-1207缓释片在轻、中度高血压患者中多次给药的药代动力学特征。
探索研究目的:
评价MT-1207缓释片在轻、中度高血压患者中多次给药的疗效。
[Translation] Part A: Primary Study Objective: To evaluate the pharmacokinetics of MT-1207 extended-release tablets with single and multiple dose escalations in healthy subjects.
Secondary Study Objectives: To evaluate the safety and tolerability of MT-1207 extended-release tablets with single and multiple dose escalations in healthy subjects; to evaluate the effect of food on the pharmacokinetics of MT-1207 extended-release tablets in healthy subjects.
Part B: Primary Study Objective: To evaluate the safety and tolerability of MT-1207 extended-release tablets with multiple doses in patients with mild to moderate hypertension.
Secondary Study Objective: To evaluate the pharmacokinetic characteristics of MT-1207 extended-release tablets with multiple doses in patients with mild to moderate hypertension.
Exploratory Study Objective: To evaluate the efficacy of MT-1207 extended-release tablets with multiple doses in patients with mild to moderate hypertension.
PE-001 片治疗成年男性早泄(PE)受试者的有效性、安全性的随机、双盲、安慰剂对
照、多中心 II 期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial to evaluate the efficacy and safety of PE-001 tablets in the treatment of adult male premature ejaculation (PE) subjects
以安慰剂为对照,探索不同剂量 PE-001 片治疗男性早泄受试者的有效性;
[Translation] Using placebo as control, explore the effectiveness of different doses of PE-001 tablets in treating male subjects with premature ejaculation;
MT-1207片治疗轻、中度原发性高血压的有效性和安全性的随机、双盲、安慰剂和阳性药物平行对照、多中心II期临床试验
[Translation] A randomized, double-blind, placebo- and active drug-controlled, multicenter Phase II clinical trial of the efficacy and safety of MT-1207 tablets in the treatment of mild and moderate essential hypertension
MT-1207片治疗轻、中度原发性高血压的有效性和安全性的随机、双盲、安慰剂和阳性药物平行对照、多中心II期临床试验
[Translation] A randomized, double-blind, placebo- and active drug-controlled, multicenter Phase II clinical trial of the efficacy and safety of MT-1207 tablets in the treatment of mild and moderate essential hypertension
100 Clinical Results associated with Yuanyan Pharmaceutical Port Life Science Research (Liaoning) Co., Ltd.
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