Health Condition 1: C61- Malignant neoplasm of prostate Health Condition 2: null- Prostate Carcinoma
Conditions
Interventions
Intervention1: Leuprolide Acetate Depot suspension 7.5 mg of Sun Pharmaceutical Industries Limited: In each of the two study periods, single dose (7.5 mg) of either Test product (A) or
Reference produ
Sponsors
Sun Pharmaceutical Industries Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be considered for enrolment in the study: 1. Prostatic carcinoma male patients undergoing initial therapy, between 18-75 years (both inclusive) of age, patientâ??s body mass index (BMI) must be within 18.5 â?? 30.0 (Kg/m2). 2. Patients whose life expectancy is greater than or equal to 6 months. 3. Subjects with Performance 4. Patient willing to give written consent (Patient Information Sheet and Informed Consent Form) prior to enrollment in the study. 5.Patients must have clinically acceptable results for all the screening and check-in laboratory parameters and investigations. 6.Availability of patient for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
Exclusion criteria
Exclusion criteria: Subject who meets any of the exclusion criteria shall not be enrolled for this study: 1. Evidence of renal, hepatic, cardiovascular or psychiatric illness which in the judgment of investigator will make the subject inappropriate to include in the study. 2. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any drug or excipients. 3. Patients with a history of alcohol, drug or substance abuse in the past 12 months. 4. Patients deemed uncooperative or noncompliant. 5. Female subjects 6. Patients who have evidence of underlying disease which in the judgment of the investigator would make the patient inappropriate for getting enrolled in the study (except Prostatic carcinoma). 7. Smoking or consumption of tobacco products. 8. Patients who have participated in another clinical study for at least 90 days prior to period- I dosing. 9. Difficulty in coming for follow up. 10. Patients determined by the study physician/Investigator to have any medical condition that could jeopardize their health or prejudice the results. 11. Blood donation within 90 days prior to period-I dosing. 12. Patients who have: Systolic blood pressure 140 mm of Hg Diastolic blood pressure 90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator. Radial pulse rate 100/min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the comparative bioavailability between Test product (Leuprolide Acetate Depot suspension 7.5 mg of Sun Pharmaceutical Industries Limited) and Reference product (Lupron Depot (Leuprolide Acetate) Depot suspension 7.5 mg of Abbvie Inc.) in Prostatic carcinoma patients under fasting condition.Timepoint: At the end of the study when all 20 patients have completed the study | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of Test product (A) and Reference product (B) in Prostatic Carcinoma patients.Timepoint: At the end of the study when all 20 patients have completed the study | — |
Countries
India
Contacts
Public ContactMr Sharad P Kholambe
Sun Pharmaceutical Industries Ltd
Outcome results
None listed