Clinical Trial

A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects

Not Yet Recruiting Phase 1
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Record status
This record was last updated December 31, 2024 (before its estimated January 9, 2025 completion). Its status may not reflect the trial's current state.
Summary
To investigate the pharmacokinetics of the test preparation abalparatide injection and the reference preparation abalparatide injection (Tymlos®) in healthy adult subjects under fasting state, and to evaluate the bioequivalence of the two formulations under fasting state.
Trial Details
NCT Number NCT06753864
Lead Sponsor The Affiliated Hospital of Qingdao University
Conditions Osteoporosis
Enrollment 32 participants
Start Date 2025-01-02
Primary Completion 2025-01-09 (estimated)
Study Completion 2025-05-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-31