CTRI/2012/02/002436 [Registered on: 21/02/2012] Trial Registered Prospectively
Last Modified On:
12/02/2013
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
To monitor safety and assess bioequivalence of Leuprolide Acetate 7.5 mg Depot suspension of Sun Pharmaceutical Industries Limited,India and Lupron Depot 7.5 mg depot suspension of TAP Pharmaceutical Inc., USA under fasting conditions in prostatic carcinoma patients undergoing initial therapy.
Scientific Title of Study
A RANDOMIZED, OPEN LABEL, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE,SINGLE DOSE, CROSSOVER, BIOEQUIVALENCE STUDY OF LEUPROLIDE ACETATE 7.5 MG DEPOT SUSPENSION OF SUN PHARMACEUTICAL INDUSTRIES LIMITED, INDIA AND LUPRON DEPOT (LEUPROLIDE ACETATE) 7.5 MG DEPOT SUSPENSION OF TAP
PHARMACEUTICAL INC., LAKE FOREST, IL 60045, USA, UNDER FASTING CONDITIONS, IN 60 PROSTATIC CARCINOMA PATIENTS UNDERGOING INITIAL THERAPY.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
LPL_7.5 I_3080_10 (a), V-00 on 09/06/11, A-01 on 09/06/11
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shravanti Bhowmik
Designation
Medical Advisor
Affiliation
Sun Pharma Advanced Research Company Ltd.
Address
Sun Pharma Advanced Research Company Ltd.
17-B, Mahal Industrial Estate,
Mahakali Caves Road, Andheri (East), Mumbai – 400093 (India)
Mumbai MAHARASHTRA 400093 India
Phone
912266455645
Fax
912266455685
Email
shravanti.bhowmik@sparcmail.com
Details of Contact Person Scientific Query
Name
Dr Shravanti Bhowmik
Designation
Medical Advisor
Affiliation
Sun Pharma Advanced Research Company Ltd.
Address
Sun Pharma Advanced Research Company Ltd.
17-B, Mahal Industrial Estate,
Mahakali Caves Road, Andheri (East), Mumbai – 400093 (India)
Mumbai MAHARASHTRA 400093 India
Phone
912266455645
Fax
912266455685
Email
shravanti.bhowmik@sparcmail.com
Details of Contact Person Public Query
Name
Dr Shravanti Bhowmik
Designation
Medical Advisor
Affiliation
Sun Pharma Advanced Research Company Ltd.
Address
Sun Pharma Advanced Research Company Ltd.
17-B, Mahal Industrial Estate,
Mahakali Caves Road, Andheri (East), Mumbai – 400093 (India)
Melmaruvathur Adhiparasakthi Institute of Medical Science and Research
Melmaruvathur Adhiparasakthi Institute of Medical Science and Research
Melmaruvathur-603319,
Tamilnadu, India.
Consultarion Room No: Ground floor - 01
Kancheepuram TAMIL NADU
04427528302 0447528305 vguro@rediffmail.com
Dr HM Yathish Kumar
NRR Hospital
NRR Hospital
Near Janapriya apartment
Chikkasandra (Near Chikkabanavara Railway Station) Hesargatta main road
Bangalore KARNATAKA
09880462912 08028374117 dryathish@hotmail.com
DrSudhir Rawal
Rajiv Gandhi Cancer Institute & Research centre
Rajiv Gandhi Cancer Institute & Research centre
Basement, B Block, Old Building, Sector - 5
Rohini Consulting Room No.2058
New Delhi DELHI
Leuprolide Acetate 7.5 mg Depot suspension of Sun Pharmaceuticalb Industries Limited, India
A single intramuscular injection in the muscle (intragluteally) in the buttock region.
Comparator Agent
Lupron Depot® (Leuprolide Acetate) 7.5 mg depot Suspension of TAP Pharmaceutical Inc., Lake Forest, IL 60045, USA,
A single intramuscular injection in the muscle (intragluteally) in the buttock region.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Male
Details
Volunteers meeting all of the following criteria will be considered for enrollment in the study:
i. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements.
ii. Prostatic carcinoma patients undergoing initial therapy, at least 18-years of age or older, subject’s body mass index (BMI) must be within 18.5 – 30.0 (Kg/m2).
iii. Subjects who have no evidence of underlying disease (Except Prostatic carcinoma) during screening medical history and whose physical examination is performed within 28 days prior to commencement of the study.
iv. Patients whose life expectancy of greater than or equal to 6 months.
v. Subjects whose screening laboratory values are within normal limits or considered by the Investigator/sub-Investigator to be of no clinical significance.
vi. The subject must sign the written consent form (subject Information and Consent Form) prior to study entry.
ExclusionCriteria
Details
1. History or presence of significant:
i. Allergy or Significant history of hypersensitivity to Leuprolide and/or any of the excipients in Leuprolide depot and GnRH, GnRH agonist analogs.
ii. Evidence of severe renal, hepatic, cardiovascular or psychiatric illness.
iii. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
iv. Smoking or consumption of tobacco products.
v. Difficulty in coming for follow up.
vi. Clinically significant illness (except defined in section 6.4 ii) within 4 weeks before the start of the study
vii. Positive result to HIV, HCV, RPR and HBsAg.
viii. Abnormal 12 lead ECG, X-ray.
2. Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study
3. Participation in another clinical trial within the preceding 90 days of study starts.
4. Subjects who have:
i. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
ii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the Investigator.
iii. Pulse rate below 60/min. or above 100/min.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1) To characterize the rate and extent of bioavailability of the test products in comparison with the reference product after single dose administration under fasting conditions,
2) Monitor the safety of the subjects participating in the study and the tolerability of the test products in comparison with the reference considering adverse events.
Pre-dose blood sample: 10 ml will be collected within a period of 15 minute before dosing.
Post dose sample :0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.0, 72.0, 168.0, 360.0, 504.0 and 672.0 hours post dosing (1 x 3 ml each) in plain vacutainers in each period.
Note:The 672.00hr post dose sampling for period I will be consider as the predose blood samples for period.
Secondary Outcome
Outcome
TimePoints
NA
NA
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is a randomized, multi center, open label, two treatment, two period, two sequence, single dose, crossover study for monitoring the safety of the subjects participating in the study and to assess the bioequivalence of Leuprolide Acetate 7.5 mg Depot suspension of Sun Pharmaceutical Industries Limited, India and Lupron Depot (Leuprolide Acetate) 7.5 mg depot Suspension of TAP Pharmaceutical Inc., Lake Forest, IL 60045, USA, under fasting conditions in 60 Prostatic carcinoma patients undergoing initial therapy.