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A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers.
Raykova, Ekaterina; Farmahini Farahani, Mohammad; Ivanova, Stanislava; Azhdarzadeh, Morteza.
  • Raykova E; Phase I Clinical Research Unit, Comac Medical Ltd., Sofia, Bulgaria.
  • Farmahini Farahani M; CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran.
  • Ivanova S; CinnaGen Research and Production co., Alborz, Iran.
  • Azhdarzadeh M; Biometrics Group, Comac Medical Ltd., Sofia, Bulgaria.
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.
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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

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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