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

A randomized, open label, two-stage, two-part, two-sequence, two-way crossover study in normal healthy adult volunteers to assess the bioequivalence of two formulations of darbepoetin alfa administered by two different routes of administration

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/09/006222

Enrollment

Registered

2015-09-29

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: DRL_DA (Darbepoetin): 60 Î¼g s.c. (part A) or 40 Î¼g i.v. (part B) on Day 1 for each treatment period. Control Intervention1: AranespÂ® (darbepoetin): 60 Î¼g s.c. (part A) or 40 Î¼g i.v

Eligibility

Inclusion criteria

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 •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

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters Cmax, AUC(0-â??) and AUC(0-t) compared to those of AranespÂ®Timepoint: 3 weeks	—

Secondary

Measure	Time frame
i. Other pharmacokinetic endpoints: t1/2, CL (Study Part B, i.v. route), CL/f (Study Part A, s.c. route) ii. Pharmacodynamic endpoints: reticulocyte count AUEC, maximum change in reticulocyte count, maximum change in haemoglobin and haematocrit (haemoglobin AUEC and haematocrit AUEC). iii. Safety and tolerability of all treatments as assessed by vital signs, adverse events, physical examination, ECG, clinical laboratory safety and immunogenicity data Timepoint: 6 weeks	—

Measure

Time frame

i. Other pharmacokinetic endpoints: t1/2, CL (Study Part B, i.v. route), CL/f (Study Part A, s.c. route) ii. Pharmacodynamic endpoints: reticulocyte count AUEC, maximum change in reticulocyte count, maximum change in haemoglobin and haematocrit (haemoglobin AUEC and haematocrit AUEC). iii. Safety and tolerability of all treatments as assessed by vital signs, adverse events, physical examination, ECG, clinical laboratory safety and immunogenicity data Timepoint: 6 weeks

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Countries

India

Contacts

Public ContactK Ranjith

Dr. Reddyâ??s Laboratories Ltd.

sonicabatra@drreddys.com91-40-44644000

Outcome results