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

Phase 1

Completed

• Conditions: The pharmacokinetic and pharmacodynamic profile of two preparations of pegfilgrastim in healthy volunteers; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12612000920897
• Lead Sponsor: Dr. Reddy’s Laboratories (DRL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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 Criteria

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified