Chengdu Dikang Pharmaceutical Co., Ltd.

Main objectives: 1. To quantitatively analyze the total radioactivity in the excreta of healthy male subjects after a single oral administration of [14C]DDCI-01, and obtain the total recovery rate of human radioactivity, radioactivity excretion data and major excretion pathways; 2. To quantitatively analyze the total radioactivity in whole blood and plasma of healthy male subjects after a single oral administration of [14C]DDCI-01, obtain the pharmacokinetic parameters of total radioactivity in whole blood (if applicable) and plasma, and investigate the distribution of total radioactivity in whole blood and plasma; 3. To quantitatively analyze the radioactive metabolite profiles in human plasma, urine and feces of healthy male subjects after a single oral administration of [14C]DDCI-01, identify the major metabolites, and determine the metabolic pathways and elimination pathways of DDCI-01 in the human body. Secondary objectives: 1. To quantitatively analyze the concentrations of DDCI-01 and its metabolites (if applicable) in plasma using a validated high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) method and obtain the pharmacokinetic parameters of DDCI-01 and its metabolites (if applicable) in plasma; 2. To observe the safety of [14C]DDCI-01 after a single oral administration in healthy male subjects.

Primary objective: To evaluate the efficacy of different doses of DDCI-01 capsules in improving the total score of the International Prostate Symptom Score (IPSS) and the International Index of Erectile Function-Erectile Function (IIEF-EF) after 12 weeks of treatment in men with lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH-LUTS) and erectile dysfunction (ED), so as to make decisions for subsequent studies. Secondary objectives: (1) To evaluate the efficacy of each dose in improving the total IPSS score at other time points during treatment. (2) To evaluate the efficacy of each dose in improving the IIEF-EF score at other time points during treatment. (3) To evaluate the efficacy of each dose in improving IPSS subgroup scores and quality of life (QoL). (4) To evaluate the efficacy of each dose in improving the IIEF sub-scores. (5) To evaluate the efficacy of each dose in improving Questions 2 and 3 of the Sexual Activity Diary (SEP) questionnaire. (6) To evaluate the efficacy of each dose on the Patient Global Impression of Improvement (PGI-I) score and the Clinician Global Impression of Improvement (CGI-I) score. (7) To evaluate the population pharmacokinetic characteristics. (8) To evaluate the safety of each dose in men with lower urinary tract symptoms (BPH-LUTS) due to benign prostatic hyperplasia and erectile dysfunction (ED). Exploratory objectives: (1) To evaluate the effect on improving maximum urine flow rate (Qmax). (2) To evaluate the effect on improving prostate-specific antigen (PSA). (3) To evaluate the effect on improving prostate volume.

This study aimed to investigate the pharmacokinetic characteristics of pioglitazone hydrochloride tablets (15 mg) developed and produced by Chengdu Dikang Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Pioglitazone hydrochloride tablets (Actos®, 15 mg) produced by Takeda Pharmaceutical Company Limited, Hikari Plant, licensed by Teva Takeda Yakuhin Ltd, were used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the bioequivalence of the two preparations in humans was evaluated, and the safety of the two preparations in healthy subjects was observed.