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一项在健康参与者中评估HRN77片安全性、耐受性的随机、双盲、安慰剂对照的I期临床研究
[Translation] A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety and tolerability of HRN77 tablets in healthy participants.
主要目的:
1.评价在健康参与者中单次、多次口服HRN77片后的安全性、耐受性;
2.评价食物对HRN77片药代动力学的影响。
次要目的:
1.评价在健康参与者中单次、多次口服HRN77片后的药代动力学特征;
2.评价HRN77片在健康参与者中的代谢与排泄特征;
3.评价HRN77片单次和多次给药后对健康参与者QTc间期的影响;
4.评价健康参与者在餐后状态下口服HRN77片的安全性和耐受性。
探索性目的:
探索在健康参与者中多次口服HRN77片后的药效学指标。
[Translation] Primary Objectives:
1. To evaluate the safety and tolerability of HRN77 tablets after single and multiple oral administrations in healthy participants;
2. To evaluate the effect of food on the pharmacokinetics of HRN77 tablets.
Secondary Objectives:
1. To evaluate the pharmacokinetic characteristics of HRN77 tablets after single and multiple oral administrations in healthy participants;
2. To evaluate the metabolic and excretion characteristics of HRN77 tablets in healthy participants;
3. To evaluate the effect of single and multiple administrations of HRN77 tablets on the QTc interval in healthy participants;
4. To evaluate the safety and tolerability of HRN77 tablets administered orally in a postprandial state in healthy participants.
Exploratory Objective: To explore the pharmacodynamic parameters after multiple oral administrations of HRN77 tablets in healthy participants.
一项在健康参与者中评估HRL1101散安全性、耐受性的随机、双盲、安慰剂及阳性药对照的I期临床研究
[Translation] A randomized, double-blind, placebo- and active-controlled phase I clinical study evaluating the safety and tolerability of HRL1101 powder in healthy participants.
主要目的:
评价在健康参与者中单次、多次口服HRL1101散后的安全性、耐受性。
次要目的:
1. 评价在健康参与者中单次、多次口服HRL1101散后的药代动力学特征;
2. 探索健康参与者单次口服HRL1101散后的代谢与排泄特征;
3. 评价在健康参与者中单次、多次口服HRL1101散后的药效动力学特征。
[Translation] Primary Objective: To evaluate the safety and tolerability of HRL1101 powder after single and multiple oral administrations in healthy participants.
Secondary Objectives:
1. To evaluate the pharmacokinetic characteristics of HRL1101 powder after single and multiple oral administrations in healthy participants;
2. To explore the metabolic and excretion characteristics of HRL1101 powder after a single oral administration in healthy participants;
3. To evaluate the pharmacodynamic and pharmacokinetic characteristics of HRL1101 powder after single and multiple oral administrations in healthy participants.
一项在健康受试者中评估HRN01片安全性、耐受性的随机、双盲、安慰剂对照的I期临床研究
[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety and tolerability of HRN01 tablets in healthy subjects
主要目的:
1.评价在健康受试者中单次、多次口服HRN01片后的安全性、耐受性;
2.评价食物(高脂高热量餐)对HRN01片药代动力学的影响。
次要目的:
1.评价在健康受试者中单次、多次口服HRN01片后的药代动力学特征;
2.评价HRN01片在健康受试者中的代谢与排泄特征;
3.评价HRN01片单次给药后对健康受试者QTc间期的影响;
4.评价健康受试者在餐后状态下(高脂高热量餐)口服HRN01片的安全性和耐受性。
探索性目的:
探索在健康受试者中多次口服HRN01片后的药效学指标。
[Translation] Main objectives:
1. To evaluate the safety and tolerability of HRN01 tablets after single and multiple oral administration in healthy subjects;
2. To evaluate the effect of food (high-fat and high-calorie meal) on the pharmacokinetics of HRN01 tablets.
Secondary objectives:
1. To evaluate the pharmacokinetic characteristics of HRN01 tablets after single and multiple oral administration in healthy subjects;
2. To evaluate the metabolism and excretion characteristics of HRN01 tablets in healthy subjects;
3. To evaluate the effect of single administration of HRN01 tablets on the QTc interval of healthy subjects;
4. To evaluate the safety and tolerability of oral administration of HRN01 tablets in healthy subjects in the postprandial state (high-fat and high-calorie meal).
Exploratory objectives:
To explore the pharmacodynamic indicators of HRN01 tablets after multiple oral administration in healthy subjects.
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