This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
5 mg, single subcutaneous injection in the abdominal region
5 mg, single subcutaneous injection in the abdominal region
5 mg, single subcutaneous injection in the abdominal region
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGPeak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax)
Time frame: 0 to 672 hours
Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 0 to 672 hours
Monitor all the adverse event
Monitor all the adverse event was assessed by the investigator.
Time frame: 29 days
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