Darbepoetin Alfa

Phase 1

• Registration Number: CTRI/2020/07/026718
• 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 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. 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%].

3.Adequate Iron [Adequate iron stores (transferrin saturation >=20% and

serum ferritin >=200 ng/mL or within laboratory reference range), total iron

binding capacity within laboratory reference.

4. Adequate levels of hemoglobin at baseline (120 g/L to 150 g/L)

5. Adequate levels of hematocrit at baseline (41% to 49%)

Exclusion Criteria

1. History of allergic responses or hypersensitivity 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. Subjects with psychiatric disorders or other conditions that can affect

the ability of the subject to follow the study protocol

4. Subjects having history of Epileptic seizures within six months prior to

the first administration of the investigational product

5. Acute infections within 4 weeks before the start of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cmax after 1st and 4th dosing of Darbepoetin alfa <br/ ><br>2. AUC0-72 after 1st and 4th dosing of Darbepoetin alfa <br/ ><br>3. Darbepoetin alfa AUCi <br/ ><br>4. Darbepoetin alfa Tmax <br/ ><br>5. Darbepoetin alfa Cmax <br/ ><br>6. Darbepoetin alfa t1/2 <br/ ><br>7. Darbepoetin alfa KelTimepoint: 1. after 1st and 4th dosing of Darbepoetin alfa <br/ ><br>2. after 1st and 4th dosing of Darbepoetin alfa <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. AUEC1-29 <br/ ><br>Timepoint: After 1st Dose <br/ ><br>