A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers.
Expert Opin Biol Ther
; 22(2): 235-243, 2022 Feb.
Article
in English
| MEDLINE | ID: covidwho-1821662
ABSTRACT
BACKGROUND:
P044 is a proposed biosimilar candidate of Teriparatide for reference medicine, Forsteo®. This study was designed to evaluate the Pharmacokinetic/Pharmacodynamic (PK/PD) bioequivalence between P044 and Forsteo®.METHODS:
In this randomized, open-label, single-dose, crossover study, 66 healthy female subjects were randomized to receive P044 and Forsteo®. The primary PK endpoints of the study were the area under the concentration versus time from zero to infinity (AUC0-inf) and maximum plasma concentration (Cmax). Secondary endpoints included area under the concentration versus time from zero to the last quantifiable concentration (AUC0-last) and Cmax for PD parameter, additional PK parameters and safety.RESULTS:
Sixty-six subjects were enrolled in the study and baseline demographics were similar between the two treatments. The two treatments presented similar PK/PD parameters and the 90% confidence interval for primary and secondary endpoints were within the bioequivalence acceptance range (80.00-125.00%) for all parameters. None of the subjects experienced serious adverse event, and all of the reported adverse events were mild and similar between two treatments.CONCLUSIONS:
This study demonstrated the PK/PD similarity of P044 to reference medicine, Forsteo® and safety profiles were comparable between treatments. TRIAL REGISTRATION EudraCT Number 2019-004477-82.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Biosimilar Pharmaceuticals
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Female
/
Humans
Language:
English
Journal:
Expert Opin Biol Ther
Journal subject:
Biology
/
Therapeutics
Year:
2022
Document Type:
Article
Affiliation country:
14712598.2021.1970742
Similar
MEDLINE
...
LILACS
LIS