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A randomized, double-blind, three-arm, balanced, single-dose, parallel-group study comparing pharmacokinetics and pharmacodynamics of Intas Denosumab (120 mg/1.7 mL) of Intas Pharmaceuticals Limited, India with Xgeva® of Amgen Inc., USA and Xgeva of Amgen Europe B.V., The Netherlands in normal, healthy, adult human male subjects

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Trial Profile

A randomized, double-blind, three-arm, balanced, single-dose, parallel-group study comparing pharmacokinetics and pharmacodynamics of Intas Denosumab (120 mg/1.7 mL) of Intas Pharmaceuticals Limited, India with Xgeva® of Amgen Inc., USA and Xgeva of Amgen Europe B.V., The Netherlands in normal, healthy, adult human male subjects

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 08 Dec 2025

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Pharmacokinetics
  • Sponsors Intas Pharmaceuticals

Most Recent Events

  • 20 Nov 2025 According to Accord pharmaceuticals, the U.S. FDA granted the approval of OSVYRTI (denosumab-desu), a biosimilar to Prolia (denosumab), and JUBEREQ (denosumab-desu), a biosimilar to Xgeva (denosumab) based on the data from this and phase III (NCT05419427) trials.
  • 27 Nov 2020 New trial record

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