A Phase I, double blind, randomized, crossover, pharmacokinetic and pharmacodynamic study of single dose of 40Î¼g of Darbepoetin alfa

A Phase I, double blind, randomized, crossover, pharmacokinetic and pharmacodynamic study of single dose of 40Î¼g of Darbepoetin alfa, (manufactured by Hetero Biopharma Ltd., India.) and â??ARANESPÂ®â?? (Darbepoetin alfa Injection, manufactured by Amgen Inc., USA.) in two arms of healthy adult volunteer groups with Subcutaneous and Intravenous route of administration

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/12/016619

Enrollment

160

Registered

2018-12-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Darbepoetin (darbepoetin alfa) injection: for intravenous or subcutaneous use, 40 Î¼g. Manufactured by Hetero Biopharma Ltd., India. Control Intervention1: AranespÂ® (darbepoetin alfa)

Eligibility

Inclusion criteria

Inclusion criteria: 1.BMI: 18.5 to 30.0 weight in kg/ (height in meter)2; BMI value should be rounded off to one significant digit after decimal point (e.g., 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5). 2.Volunteer having body weight 3.Adequate liver and kidney function [AST, ALT, alkaline phosphatase and bilirubin 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin 4.Able to communicate effectively with study personnel. 5. Able to give written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. History of allergic responses to Darbepoetin alfa or other related drugs, or any of its formulation ingredients. 2. Have significant diseases or clinically significant abnormal findings during screening, [medical history, physical examination, laboratory evaluations, ECG and chest X-ray recording]. 3. Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system. 4. Hemoglobin at baseline greater than 12 g/dL.

Design outcomes

Primary

Measure	Time frame
Cmax, AUC0-tTimepoint: Maximum measured serum concentration over the time span specified. The area under the serum concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration.	—

Secondary

Measure	Time frame
AUCt/AUCiTimepoint: The ratio of AUCt to AUCi;KelTimepoint: The terminal elimination rate constant will be obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the log (base) of the concentration versus time plot for these points.;TmaxTimepoint: Time of the maximum measured serum concentration. If the maximum serum concentration occurs at more than one time point, the first is chosen as Tmax.	—

Measure

Time frame

AUCt/AUCiTimepoint: The ratio of AUCt to AUCi;KelTimepoint: The terminal elimination rate constant will be obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the log (base) of the concentration versus time plot for these points.;TmaxTimepoint: Time of the maximum measured serum concentration. If the maximum serum concentration occurs at more than one time point, the first is chosen as Tmax.

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Countries

India

Contacts

Public ContactDr Mangesh Khadakban

Nexus Clinical Research (India) Ltd.

hbo@nexuscro.com9167243914

Outcome results