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/ Not yet recruitingPhase 1 锝[99mTc]-H7ND注射液在胃肠道恶性肿瘤患者和健康志愿者体内的药代动力学和安全性的I期临床研究
[Translation] Phase I clinical study on the pharmacokinetics and safety of technetium [99mTc]-H7ND injection in patients with gastrointestinal malignancies and healthy volunteers
本研究的主要目的是:
评价锝[99mTc]-H7ND注射液在胃肠道恶性肿瘤患者和健康人中的安全性。
本研究的次要目的是:
(1)检测锝[99mTc]-H7ND注射液在健康人体内的药代动力学。
(2)检测锝[99mTc]-H7ND注射液在健康人体内的代谢稳定性。
(3)检测锝[99mTc]-H7ND注射液在胃肠道恶性肿瘤患者和健康人体内的生物分布及估算内照射辐射吸收剂量。
[Translation] The main objectives of this study are:
To evaluate the safety of technetium [99mTc]-H7ND injection in patients with gastrointestinal malignancies and healthy subjects.
The secondary objectives of this study are:
(1) To detect the pharmacokinetics of technetium [99mTc]-H7ND injection in healthy subjects.
(2) To detect the metabolic stability of technetium [99mTc]-H7ND injection in healthy subjects.
(3) To detect the biodistribution of technetium [99mTc]-H7ND injection in patients with gastrointestinal malignancies and healthy subjects and to estimate the internal radiation absorbed dose.
A Phase I Clinical Study of the Pharmacokinetics and Safety of Technetium [99mTc]-H7ND Injection in Patients With Gastrointestinal Malignancies and Healthy Volunteers
The primary objective of this study is: to evaluate the safety of technetium [99mTc]-H7ND injection in patients with gastrointestinal malignancies and in healthy subjects. The secondary objectives of this study are: (1) to examine the pharmacokinetics of technetium [99mTc]-H7ND Injection in healthy subjects. (2) Detect the metabolic stability of technetium [99mTc]-H7ND injection in healthy humans. (3) Detect the biodistribution and estimate the absorbed dose of radiation from internal irradiation of technetium [99mTc]-H7ND injection in patients with malignant tumors of the gastrointestinal tract and in healthy humans.
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Double-blind, Positive Controlled Study
Objective: To evaluate the efficacy and safety of Ningmitai Capsules and Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules.
Study design: A multicenter, prospective, randomized, double-blind, positive controlled clinical study.
Interventions:
Group A: Oral Tamsulosin Hydrochloride Capsules and Ningmitai Capsules placebo for 12 weeks.
Group B: Oral l Silodosin Capsules and Ningmitai Capsules placebo for 12 weeks. Group C: Oral l Silodosin Capsules and Ningmitai Capsules for 12 weeks.
100 Clinical Results associated with Beijing Farber Xintian Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Beijing Farber Xintian Pharmaceutical Technology Co., Ltd.
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100 Translational Medicine associated with Beijing Farber Xintian Pharmaceutical Technology Co., Ltd.