A randomized, open label, two treatment, two period, two sequence, Single dose, crossover, comparative bioavailability study of Leuprolide Acetate depot suspension 7.5 mg of Sun Pharmaceutical Industries LIMITED and Lupron Depot (Leuprolide Acetate) depot suspension 7.5 mg of Abbvie inc., under fasting condition, in prostatic carcinoma patients Undergoing initial therapy

Sun Pharmaceutical Industries Ltd India0 个研究点目标入组 21 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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 <= 2 on the ECOG performance scale (listed in Appendix-III).
•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.

•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 <90 mm of Hg or >140 mm of Hg Diastolic blood pressure <60 mm of Hg or >90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator.
•Radial pulse rate <60/min. or >100/min.

发起方

Sun Pharmaceutical Industries Ltd India