The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers. Participants will receive single-dose of either test or reference octreotide microsphere formulations. Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
A single intramuscular dose of the test octreotide microsphere 30mg,
A single intramuscular dose of the reference octreotide microsphere 30mg
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
AUC0-28d
The area under the concentration-time curve from dosing to Day 28
Time frame: Day 0-28
AUC28-56d
The area under the concentration-time curve from Day 28 to Day 56
Time frame: Day 28-56
AUC0-t
The area under the concentration-time curve from dosing to the last quantifiable time-point
Time frame: Day 0-82
AUC0-∞
The area under the concentration-time curve extrapolated to infinity
Time frame: Day 0-82
Cmax
The maximum drug concentration
Time frame: Day 0-82
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