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CTRI Number  CTRI/2016/03/006727 [Registered on: 10/03/2016] Trial Registered Prospectively
Last Modified On: 03/09/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical study to evaluate the Pharmacokinetic and Pharmacodynamic properties of Darbepoetin alfa Injection, Hetero and ‘ARANESP®’ (Darbepoetin alfa Injection, Amgen), in Healthy Adult Human Subjects 
Scientific Title of Study   A Phase-I, Pharmacokinetic and Pharmacodynamic Study of Darbepoetin alfa Injection, Hetero and ‘ARANESP®’ (Darbepoetin alfa Injection, Amgen), in Healthy Adult Human Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/DarbeHHV/09/2014, Version 1.1 dated 19-Aug-2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manish Singhal MBBS 
Designation  Principal Investigator 
Affiliation  Cliantha Research Limited 
Address  Sigma-1 Corporate, B/H. Rajpath Club, Opposite Mann Party Plot, Off. S.G, Highway, Bodakdev

Ahmadabad
GUJARAT
380054
India 
Phone  7966135601  
Fax  7966135602  
Email  MSinghal@cliantha.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen Shetty 
Designation  Asst. General Manager 
Affiliation  Hetero Drugs Limited 
Address  Hetero Corporate,7 2 A2, Industrial Estates, Sanath Nagar

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  23704923  
Fax  23801902  
Email  praveen.shetty@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhadeep Sinha MD 
Designation  Vice-President and Head 
Affiliation  Hetero Drugs Limited 
Address  Hetero Corporate,7 2 A2, Industrial Estates, Sanath Nagar

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  23704923  
Fax  23801902  
Email  sd.sinha@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Drugs Limited, Unit – III, Biologics Division, Survey no. 458, APIIC Pharma SEZ, Polepally (v), Jadcherla (m), Mahaboobnagar – 509301, Telangana, India. 
 
Primary Sponsor  
Name  Hetero Drugs Limited 
Address  Hetero Corporate”, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India Tel: 91-40-23704923/24/25; Fax: 91-40-23704926 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manish Singhal MBBS  Cliantha Research Limited  Sigma-1 Corporate, B/H. Rajpath Club, Opposite Mann Party Plot, Off. S.G, Highway, Bodakdev, Ahmedabad-380 054
Ahmadabad
GUJARAT 		 07966135601
07966135602
MSinghal@cliantha.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medilink Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Anaemia of CKD or Malignancy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aranesp® (darbepoetin alfa) injection  Aranesp® (darbepoetin alfa) injection, for intravenous or subcutaneous use, 0.75μg/kg. 
Intervention  Hetero-Darbepoetin (darbepoetin alfa)injection  Hetero-Darbepoetin (darbepoetin alfa) injection, for intravenous or subcutaneous use, 0.75μg/kg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Age:18 to 45 years old, both inclusive

2. Sex: Male and/or non-pregnant, non-lactating female
a. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to initiation of the study & prior to check-in of each period. They must be using an acceptable form of contraception
b. For female of childbearing potential, acceptable forms of contraception include the following:
i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
ii. Barrier methods containing or used in conjunction with a spermicidal agent, or
iii. Surgical sterilization or
iv. Practicing sexual abstinence throughout the course of the study
c. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or
ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iii. Total hysterectomy and an absence of bleeding for at least 3 months.

3. BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive; 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).

4. Volunteer having body weight ≤80 Kg

5. 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%].

6. Adequate Iron & Haemoglobin [Adequate iron stores (transferrin saturation ≥20% and serum ferritin ≥200 ng/mL or within laboratory reference range), total iron binding capacity, serum vitamin B12 and folate within laboratory reference range and blood haemoglobin not above 12.0 g/dL].

7. Able to communicate effectively with study personnel.


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

9. All volunteers must be judged by the principal or co-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:
a. A physical examination with no clinically significant finding.
b. Results within normal limits or clinically non-significant for the laboratory tests 
 
ExclusionCriteria 
Details  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, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers)].

3. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.

4. Haemoglobin at baseline greater than 12 g/dL

5. History or presence of bronchial asthma.

6. Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.

7. A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
8. History or evidence of drug dependence or of alcoholism or of moderate alcohol use.

9. Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.

10. History of difficulty with donating blood or difficulty in accessibility of veins.

11. A positive hepatitis screen (includes subtypes B & C).

12. A positive test result for HIV antibody and / or syphilis (RPR/VDRL).

13. Intolerance to venipuncture

14. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Co-Investigator, could contraindicate the volunteer’s participation in this study.

15. Volunteer having positive urine screen for drugs of abuse.

16. Volunteer having positive alcohol breath test.

17. Receipt of live vaccine within 4 weeks prior to the first dose of study medication. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
PK Endpoints
Cmax, AUCt and AUCi
T/R ratio will be reported for AUCt, AUCi and Cmax.

PD Endpoints
Baseline adjusted AUECHb 		 NA 
 
Secondary Outcome  
Outcome  TimePoints 
PK Endpoints
AUCt/AUCi, Tmax, Kel and t1/2 		 NA 
PD Endpoints
Change in haematocrit, Change in reticulocyte count, Maximum Hb, Maximum hematocrit, Maximum reticulocyte count achieved 		 NA 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   11/03/2016 
Date of Study Completion (India) 10/06/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/06/2016 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a phase I, double blind, randomized, two-period, two-treatment, two-sequence, two-stage, two-part, crossover, balanced, single dose, pharmacokinetic and pharmacodynamic study of two formulations of Darbepoetin alfa administered by two different routes. 
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