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CompletedPhase 1ACTRN12612000920897

A clinical trial to compare the pharmacokinetic and pharmacodynamic profile of two preparations of pegfilgrastim

A Double-blind, Randomised, Controlled, 3 Cohort, Dose ranging, Crossover, Pharmacokinetic and Pharmacodynamic Study of Two Preparations of Pegfilgrastim in Healthy Subjects

Sponsor

Dr. Reddy’s Laboratories (DRL)

Enrollment

36 participants

Start Date

Oct 24, 2012

Study Type

Interventional

Conditions

The pharmacokinetic and pharmacodynamic profile of two preparations of pegfilgrastim in healthy volunteers

Summary

This is a crossover dose ranging study to assess and compare the PK/PD, immunogenicity and safety profiles of two preparations of Pegfilgrastim.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria5

  • Healthy male and female subjects
  • In general good health
  • Must have normal organ function; including normal liver and renal function
  • Non-smokers or ex-smokers who have not smoked within the previous 6 months from Screening visit.
  • Subjects must be able to understand and willing to comply with the study procedures, restrictions and requirements as judged by the investigator.

Exclusion Criteria7

  • Known hypersensitivity to Escherichia coli derived proteins and/or hypersensitivity to the study drug pegfilgrastim or filgrastim or any of its ingredients.
  • History of hypersensitivity to latex.
  • Any prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or pegfilgrastim; or prior immunoglobulin preparations within the previous 6 months from Screening visit.
  • Hereditary fructose intolerance.
  • Any clinically significant laboratory findings (haematology, biochemistry and urinalysis) outside the normal laboratory range of the test laboratory (where the test will be conducted).
  • Any psychological, familial, sociological, personal (including out of town trips) or geographical conditions that do not permit compliance with the Clinical Study Protocol.
  • Hypertension, significant hypercholesterolemia as judged by the investigator, or thyroid abnormalities.

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Interventions

Comparative Dose ranging study (comparing Dr Reddy's Labs [DRL's] pegfilgrastim & Reference Medicinal Product [RMP] - Neulasta [registered trademark], a different preparation of pegfilgrastim) in a s

Comparative Dose ranging study (comparing Dr Reddy's Labs [DRL's] pegfilgrastim & Reference Medicinal Product [RMP] - Neulasta [registered trademark], a different preparation of pegfilgrastim) in a single dose, cross over design with 28 days wash out, with 3 cohorts (30,60 & 100mcg/kg by Subcutaneous [SC] injection). All participants at each dose cohort will receive both formulations of pegfilgrastim, 28 days apart.

Locations(1)

VIC, Australia

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ACTRN12612000920897