Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06753864
PHASE1

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

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-01-02

Completion Date

2025-05-01

Last Updated

2024-12-31

Healthy Volunteers

Yes

Conditions

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.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China