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

Phase 1

• Registration Number: CTRI/2018/12/016619
• Lead Sponsor: PSK Pharma LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <=80 Kg

3.Adequate liver and kidney function [AST, ALT, alkaline phosphatase and bilirubin <=1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%].

4.Able to communicate effectively with study personnel.

5. Able to give written informed consent to participate in the study.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified