A clinical trial to study the effects of bioequivalence of two formulations of darbepoetin alfa administered by two different routes of administration in normal healthy adult volunteers

Phase 1

Recruiting

• Registration Number: CTRI/2015/09/006222
• Lead Sponsor: Dr Reddys Laboratories Ltd Biologics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

•Both genders, 18-55 years (both inclusive)

•Body weight 40-80 kg and BMI 19-30 kg/m2 (both inclusive)

•AST, ALT, ALP and bilirubin <=1.5xULN

•Adequate iron stores (transferrin saturation >= 15% and serum ferritin within the reference range of the laboratory), total iron binding capacity, serum vitamin B12 and folate within the reference range and blood haemoglobin not above 15.0 g/dL.

•Agrees to use reliable means of contraception

•Voluntary written informed consent

Exclusion Criteria

Current/chronic history of

•Liver disease, or known hepatic or biliary abnormalities

•Prior haematological or oncology disease, any significant liver or kidney disease, infectious, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, psychiatric pathology

•Symptomatic hypotensive episodes associated with IV drug administration

•Seizures or convulsions within the 6 months prior to dose administration/ head trauma requiring medical care or resulting in loss of consciousness within one year prior to dose administration or any history of epilepsy

•Drug/alcohol abuse

Haemoglobin >15 g/dL

Hypertension (SBP > 140 mmHg or DBP > 90 mmHg)

Subjects on anti-hypertensive medications Positive

•Hepatitis B/ Hepatitis C/ HIV

•Urine scan for drug of abuse (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)

•Pre-study alcohol screen

Pregnant/ Lactating females

Blood donation within 90 days prior to randomization

articipation in a clinical trial and has received an investigational product within 90 days prior to enrolment in this study

Subject is mentally or legally incapacitated

Unwillingness or inability to follow the procedures outlined in the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified