Darbepoetin Alfa

A Phase I, single blind, randomized, controlled clinical study of the pharmacokinetics, pharmacodynamics, Tolerability and Safety of Multiple Intravenous Injections of Darbepoetin alfa, (manufactured by Hetero Biopharma Ltd., India.) and â??ARANESPÂ®â?? (Darbepoetin alfa Injection, manufactured by Amgen Inc., USA.) in healthy adult male volunteers.â??

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026718

Enrollment

Registered

2020-07-21

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 use, 1 Î¼g/kg. Manufactured by Hetero Biopharma Ltd., India. Control Intervention1: AranespÂ® (darbepoetin alfa) injection: for

Eligibility

Inclusion criteria

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 is acceptable if bilirubin is fractionated and direct bilirubin 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

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

Design outcomes

Primary

Measure	Time frame
1. Cmax after 1st and 4th dosing of Darbepoetin alfa 2. AUC0-72 after 1st and 4th dosing of Darbepoetin alfa 3. Darbepoetin alfa AUCi 4. Darbepoetin alfa Tmax 5. Darbepoetin alfa Cmax 6. Darbepoetin alfa t1/2 7. Darbepoetin alfa KelTimepoint: 1. after 1st and 4th dosing of Darbepoetin alfa 2. after 1st and 4th dosing of Darbepoetin alfa	—

Secondary

Measure	Time frame
1. AUEC1-29 Timepoint: After 1st Dose	—

Countries

India

Contacts

Public ContactSuresh Chandra

Camus Pharma

suresh@camuspharma.com

Outcome results