Include Ankle Brachial Index test to exclude peripheral artery disease: CDSCO Panel Tells Lupin on Denosumab PK/PD study
New Delhi: The drug major Lupin has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a pharmacokinetic and pharmacodynamic study (PK/PD) to compare pharmacokinetic, pharmacodynamic and immunogenicity of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) and Prolia (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy adult male subjects.
However, this approval is subject to a condition that the screening tests must include an Ankle Brachial Index test to rule out peripheral artery disease in exclusion criteria.
This came after the drug major Lupin presented the protocol to conduct a PK/PD study titled “Single dose study to compare pharmacokinetic, pharmacodynamic and immunogenicity of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) and Prolia (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy adult male subjects” vide Protocol No. C1B03215, Version 01 dated 15 Jun 23.
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