Guangzhou Bosto Controlled-Release Pharmaceutical Co Ltd.

The efficacy and safety of the combination of olmesartan medoxomil/amlodipine/hydrochlorothiazide tablets in the treatment of patients with essential hypertension were evaluated using the combination of olmesartan medoxomil/hydrochlorothiazide tablets as a control. The primary endpoint was the change in mean sitting diastolic blood pressure (msDBP) from randomization to the end of the 8-week double-blind treatment period. The secondary endpoints were the change in mean sitting systolic blood pressure (msSBP) from randomization to the end of the 8-week double-blind treatment period; the change in msDBP and msSBP from randomization to the end of the 4-week double-blind treatment period; and the percentage of subjects who reached the target blood pressure [msSBP/msDBP < 140/90 mmHg or msSBP/msDBP < 130/80 mmHg in patients with diabetes or chronic kidney disease (creatinine clearance ≥ 30 mL/min and ≤ 60 mL/min)] at the end of the 4th and 8th weeks of the double-blind treatment period.

Primary objective: To evaluate the pharmacokinetic characteristics of the test formulation Paclitaxel (albumin-bound) 100 mg (manufactured by Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd.) and the reference formulation ABRAXANE® Paclitaxel (albumin-bound) 100 mg (manufactured by Abraxis BioScience, LLC) in patients with metastatic breast cancer who have failed combination chemotherapy or relapsed within 6 months after adjuvant chemotherapy and to determine the bioequivalence between the two formulations. Secondary objective: To monitor adverse events and ensure safety in patients.