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CTRI Number  CTRI/2025/09/095472 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   ORAL BIOEQUIVALENCE STUDY OF HYDROXYUREA CAPSULES, USP 500 MG COMPARED WITH HYDREA® (HYDROXYUREA CAPSULES, USP) 500 MG IN ADULT, HUMAN PATIENTS WITH SICKLE CELL ANEMIA UNDER FASTING CONDITIONS. 
Scientific Title of Study   An Open-Label, Balanced, Randomized, Multi-Center, Single-Dose, Two-Treatment, Two-Period, Two-Sequence, Two-Way Crossover, Oral Bioequivalence Study of Hydroxyurea Capsules, USP 500 Mg (Test Product) Compared with Hydrea® (Hydroxyurea Capsules, USP) 500 Mg (Reference Product) in Adult, Human Patients with Sickle Cell Anemia Under Fasting Conditions. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
HYDR-24-064, Version No. 01, Date: 07-Jul-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shanmugarajan 
Designation  Medical Monitor 
Affiliation  Scitus Pharma Services Private Limited 
Address  Module Nos. 32, 33, 34, 35, 36, and 37,2nd Floor, SIDCO Multi-Storeyed Complex, SIDCO Industrial Estate, Thirumazhisai

Chennai
TAMIL NADU
600124
India 
Phone  9715785821  
Fax    
Email  shanmugarajan.b@scitusbiolab.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shanmugarajan 
Designation  Medical Monitor 
Affiliation  Scitus Pharma Services Private Limited 
Address  Module Nos. 32, 33, 34, 35, 36, and 37,2nd Floor, SIDCO Multi-Storeyed Complex, SIDCO Industrial Estate, Thirumazhisai

Chennai
TAMIL NADU
600124
India 
Phone  9715785821  
Fax    
Email  shanmugarajan.b@scitusbiolab.com  
 
Details of Contact Person
Public Query  
Name  Dr S D Rajendran 
Designation  Director and Head-Operations 
Affiliation  Scitus Pharma Services Private Limited 
Address  Module No. 32,33,34,35,36 and 37, 2nd Floor, SIDCO Multi-Storeyed Complex, SIDCO Industrial Estate, Thirumazhisai

Chennai
TAMIL NADU
600124
India 
Phone  9940306042  
Fax    
Email  sd.rajendran@scitusbiolab.com  
 
Source of Monetary or Material Support  
Esjay Pharma Pvt. Ltd, Plot No G 28 & 29, 12th Main Road, SIPCOT Industrial Park, Irungattukottai-602117, Tamilnadu, India.  
 
Primary Sponsor  
Name  Esjay Pharma Pvt. Ltd. 
Address  Plot No G 28 and 29, 12th Main Road, SIPCOT Industrial Park, Irungattukottai-602117, Tamilnadu, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Scitus Pharma Services Private Limited   SF NO. 534/4A2B, Chettinadu Hospital Road 102 Samy Apartments, 27 Ponnu Green Farm Padur Chennai - 603103 Tamil Nadu  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chirag Rathod  GMERS Medical College & Hospital   Medicine Department, Room no. 601, 6th floor Hospital Building Gotri Road, Vadodara-390021, Gujarat, India. Vadodara GUJARAT
Vadodara
GUJARAT 		 9909035630

chirag_rthd@rediffmail.com 
Dr Keyur Madan Brahme   SSG Hospital, Medical College   Medicine Dept ,Clinical study room 1,6th floor, New Ext. Building Jail Road, Vadodara- 390001 Vadodara GUJARAT
Vadodara
GUJARAT 		 9727729105

keyurbrahme@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human  Approved 
Institutional Human Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D570||Hb-SS disease with crisis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  HYDREA® (Hydroxyurea Capsule USP 500 mg) - Control Group   HYDREA® (Hydroxyurea Capsule USP 500 mg) with total duration of 10 days 
Intervention  Hydroxyurea Capsule USP 500 mg - Study group  Hydroxyurea Capsule USP 500 mg with total duration of 10 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patients of either gender (Male or non-pregnant and non-lactating Female) with the age of 18 – 55 years of age with confirmed diagnosis of sickle cell anemia with recurrent painful crises (1 to 6 pain crises in the last 6 months)
2. Patients who are already on a stable dosing regimen of hydroxyurea (1000 mg taken once daily) for at least 24 weeks prior to screening visit in the study
3. Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements
4. Adequate Hematopoietic, Renal and Hepatic function defined as the following Body System Parameters
Platelet count greater than or equal to 100,000/mm3
Haemoglobin greater than 9.0 g/dL
Hepatic function ALT&AST less than or equal to 2.5 × ULN
Total Bilirubin less than or equal to 3.5 mg/dL
Renal function Creatinine clearance greater than or equal to 60 ml/min
Serum Creatinine less than 3 x ULN
Able to comply with study requirement in opinion of Principal Investigator
6. Males of reproductive potential must agree to use effective contraception [including use of barrier methods (male condom, spermicide), behavioral methods (abstinence) or vasectomy] or the female partners of these patients must agree to use an effective method of avoiding pregnancy during the study and for atleast 6 months after the last dose of study drug
7. Females of childbearing potential must have a negative beta-HCG pregnancy test at screening and negative urine pregnancy test at the time of screening and study site check-in
. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] 14 days prior to study drug administration, during study and for atleast 6 months after the last dose of study drug
9. Non-smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months
10. Patients having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording
11. Patients having a normal or clinically not significant chest X-Ray.
12. Patients with Systolic blood pressure between ≥90 to ≤140 mmHg and diastolic blood pressure between ≥60 to ≤ 90 mmHg and heart rate within 60 to 100 bpm at screening & check-in 
 
ExclusionCriteria 
Details  1. History of hypersensitivity to hydroxyurea or any other component of its formulation as judged by the investigator
2. History of a myeloproliferative disease, diffuse pulmonary infiltrates or pulmonary fibrosis
3. History of therapy with central nervous system inhibitor or antitumor agents (e.g. 5-fluorouracil) within 28 days before the first administration of investigational product
4. History of therapy with interferon or antiretroviral agents (e.g. didanosine, stavudine and indinavir) within 28 days before the first administration of investigational product
5. Patients with leukemia of any type
6. Uncontrolled systemic infection
7. Cardiac diseases including congestive heart failure, atrial or ventricular arrhythmia
8. History of drug/alcohol addiction
9. Pregnant or lactating females
10. Patients found to be positive for HIV, Hepatitis B or C, VDRL at screening visit
11. Patients requiring dosing with any of the live vaccines.
12. Patients suffering from gout
13. Patients with skin cancer or other secondary malignancies
14. Patients with cutaneous vasculitic toxicities, including vasculitic ulcerations, gangrene, etc
15. Patients with history of diagnosis of macrocytosis or pernicious anemia
16. Patients with a history of tumor lysis syndrome, disorientation, hallucinations, convulsions etc. following treatment with hydroxyurea
17. Patients who have received radiation therapy in the past for any reason
18. Donation of blood or any blood loss within 90 days prior to receiving the first dose of study drug
19. Inadequate venous access for PK sampling as judged by investigator
20. Requirement of any planned procedure or hospitalization for pre-existing conditions during the study period
21. Use of any OTC medicinal products (including herbal remedies) during the 05 days prior to check-in and inability to abstain during the study
22. Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.),
cigarettes and tobacco containing products, recreational drugs for at least 48.00 hours prior to check-in and inability to abstain during the study
23. Consumption of alcohol and its products, grapefruit and/or its juice and poppy-containing foods within 72.00 hours prior to check-in and inability to abstain during the study
24. Patients found positive on urine scan for drugs of abuse and/or breath / other relevant test for alcohol consumption at study site check-in
25. The receipt of an investigational product or participation in other drug research study within a period of 90 days prior to the first dose of study drug for the current study
26. Patients with any significant history of non-compliance or inability to reliably grant informed consent
27. Significant blood loss/hemorrhage leading to hemodynamic instability as judged by Investigator
28. Patients with difficulty in swallowing the study drug 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the oral bioequivalence of Hydroxyurea Capsules, USP 500 mg (T) with HYDREA® (Hydroxyurea Capsules, USP) 500 mg (R) in adult, human patients with sickle cell anemia under fasting conditions.  PK samples will be collected at day 2 of visit 2 and day 2 of visit 3  
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of a single dose of an Investigational Product in adult, human patients with sickle cell anemia under fasting conditions.  PK samples will be collected at day 2 of visit 2 and day 2 of visit 3  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study will be an open labelled, randomized, multicenter, single dose, two treatments, two periods, two sequence, two-way cross-over oral bioequivalence study. A total of 36 Sickle Cell Anemia patients will be included based on inclusion exclusion criteria. The study duration will be about 10 days per patient (from Day 00 of Period 1 check-in to Day09 period 02 checkout) including washout period (interval between 2 drug administrations) of at least by 07 days. The screening will be performed within 28 days before period 01 check-in. Study drug will be administered with 240 mL of water as per the randomization. Blood samples will be collected in scheduled time points. During study patient safety assessment (physical exam, temperature, BP, pulse rate) will be measured and post study clinical lab assessment will be performed for all the dosed patients. Bioanalysis will be done using validated method. Pharmacokinetic analysis will be performed using Phoenix® WinNonlin® software and statistical analysis will be performed using SAS® system. The study is not published in any literature or online journal.  
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