| CTRI Number |
CTRI/2013/08/003923 [Registered on: 27/08/2013] Trial Registered Prospectively |
| Last Modified On: |
13/05/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of hydroxyurea capsule in patients of sickle cell anemia |
|
Scientific Title of Study
|
A Randomized, Open Label, Two-Treatment, Single Dose, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Hydroxyurea Capsules 500 mg of Blau Farmaceutica, Brazil with Hydrea (Hydroxyurea Capsules) 500 mg of Brystol-Myers Squibb Co., Brazil in Adult Patients Suffering from Sickle Cell Anemia under Fasting Conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL/CT/11/045 version 02 dated 14-Feb-12 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Jani |
| Designation |
Asst. GM, Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt. Ltd. |
| Address |
Opposite The Grand Bhagwati Hotel, Sarkhej Gandhinagar Highway, Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
0917940231612 |
| Fax |
0917940029317 |
| Email |
ashutosh.jani@accutestindia.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Agam Shah |
| Designation |
Medical Expert - Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt. Ltd. |
| Address |
Opposite The Grand Bhagwati Hotel, Sarkhej Gandhinagar Highway, Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
0917940231612 |
| Fax |
0917940029317 |
| Email |
agam.shah@accutestindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Prasann Bavania |
| Designation |
Project Manager |
| Affiliation |
Accutest Research Laboratories (I) Pvt. Ltd. |
| Address |
Opposite The Grand Bhagwati Hotel, Sarkhej Gandhinagar Highway, Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
0917940231607 |
| Fax |
0917940029317 |
| Email |
prasann.bavania@accutestindia.com |
|
|
Source of Monetary or Material Support
|
| BLAU FARMACEUTICA
Barro Branco - Cotia/SP - CEP: 06705-030, Brazil |
|
|
Primary Sponsor
|
| Name |
BLAU FARMACEUTICA |
| Address |
Blausiegel Indústria e Comércio Ltda
Rodovia Raposo Tavares, 2833 Km 30,5
Barro Branco - Cotia/SP - CEP: 06705-030, Brazil |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhirendra Chaudhari |
Aastha Hospital |
Market Faliya, Mandvi-394160
Surat
GUJARAT |
0912623-222715
aastha77@yahoo.com |
| Dr Jitendra D Lakhani |
Dhiraj hospital |
Department of Medicine, Sumandeep Vidyapeeth, Pipaliya
Vadodara
GUJARAT |
0919974009181
jitendralakhani@doctor.com |
| Dr Krishnakant Niranjanbhai Bhatt |
New Civil Hospital & Govt. Medical College |
Department of Medicine, Majuragate, Surat- 395001
Surat
GUJARAT |
9825190476
knbsurat@gmail.com |
| Dr Manish Kagrecha |
Pushpak Hospital |
Ambaji naka, Mandvi-394160
Surat
GUJARAT |
0912623-223144
mkagrecha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee, Govt. Medical College & New Civil Hospital |
Submittted/Under Review |
| Independent Ethical Review Committee of Surat - Dr. Dhirendra Chaudhri |
Approved |
| Independent Ethical Review Committee of Surat - Dr. Manish Kagrecha |
Approved |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Sickle Cell Anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydrea (hydroxyurea capsules) 500 mg of Bristol-Myers Squibb CO., Brazil. |
On day 1/ day 8 (as per randomization sequence), the single designated dose (2 x capsule 500 mg e.g. 1000 mg hydroxyurea) will be administered after overnight fasting of 8 hours, with about 200 mL of water at ambient temperature, in sitting position. |
| Intervention |
Hydroxyurea capsules 500 mg of Blau Farmaceutica, Brazil |
On day 1/ day 8 (as per randomization sequence), the single designated dose (2 x capsule 500 mg e.g. 1000 mg hydroxyurea) will be administered after overnight fasting of 8 hours, with about 200 mL of water at ambient temperature, in sitting position. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 45 years (both inclusive) and either sex.
2. Diagnosed case of sickle cell anemia and not being treated with hydroxyurea.
3. Willing to give written informed consent for participation in the trial as well as willing and able to comply with study visit schedule and other protocol requirements.
4. Females of childbearing potential must have a negative beta-HCG pregnancy test as well as must be non-lactating at Screening and must agree to use an effective contraceptive method during study. |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to hydroxyurea or any other component of its formulation as judged by the investigator.
2. Abnormal laboratory results as below:
• SGOT &/or SGPT greater than 3 times upper limit of normal (ULN)
• Serum Creatinine greater than 3 times ULN
• Platelet Count less than 95,000/mm3
• Absolute neutrophils count less than 2500/ mm3
• Reticulocyte count less than 95,000/mm3
• Reactive for HIV antibody, HBsAg or HCV antibody
3. History of a myeloproliferative disease, diffuse pulmonary infiltrates or pulmonary fibrosis.
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. Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory information needed to achieve the objectives of the study.
6. Alcohol or any drug dependence within past one year.
7. Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening.
8. Blood donation/ loss exceeding 200 ml within last 60 days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess Bioequivalence of the investigational product versus comparator product |
Day 01 and Day 08. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability of single dose of the investigational product versus comparator product |
Throughout the study period till follow-up on day 15 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
20/10/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hydroxyurea stimulates the production of fetal hemoglobin in patients with sickle cell Anemia (SCA), which inhibits sickling. In a randomized placebo controlled study of adults with SCA, hydroxyurea has been reported to decrease the rates of vasoocclusive crisis, acute chest syndrome, and blood transfusion, leading regulatory authorities to approve hydroxyurea for the treatment of SCA in adults. In children with SCA, hydroxyurea treatment has been reported to significantly reduce the number of days spent in hospital and confirmed this beneficial effect. In addition to increased production of fetal hemoglobin, decreased endothelial adhesiveness and increased bioavailability of nitric oxide may mediate the therapeutic effects of hydroxyurea.
Sponsor has developed generic version of hydroxyurea capsules 500 mg. The present study aims to evaluate bioequivalence of sponsor’s test formulation against corresponding reference product in adult patients, who are diagnosed to have Sickle Cell Anemia.
Primary objective: To characterize pharmacokinetic profile of Test product – hydroxyurea capsules 500 mg of Blau Farmaceutica, Brazil, compared to that of the corresponding Reference product – Hydrea (hydroxyurea capsules) 500 mg of Bristol-Myers Squibb Co., Brazil under fasting conditions in adult patients, who are diagnosed to have Sickle Cell Anemia, and assess the bioequivalence. Secondary Objective: To monitor the safety and tolerability of a single dose of hydroxyurea capsules 500 mg in adult patients, who are diagnosed to have Sickle Cell Anemia.
|