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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 2, 2025

Primary Completion Date

January 9, 2025

Study Completion Date

May 1, 2025

Conditions
Osteoporosis
Interventions
DRUG

Test (T)

Abaloparatide injection, specification :3120 μg/1.56 ml(2000 μg/ml), drug information subject to actual supply, Qilu Pharmaceutical Co., LTD. The test preparations for the subjects are all from the same batch number.

DRUG

Reference (R)

Abaloparatide injection (Tymlos®), specification :3120 μg/1.56 ml(2000 μg/ml), drug information is subject to actual supply, provided by Qilu Pharmaceutical Co., LTD. The reference preparations for the subjects were all from the same batch number.

Trial Locations (1)

266003

The Affiliated Hospital of Qingdao University, Qingdao

All Listed Sponsors
lead

The Affiliated Hospital of Qingdao University

OTHER