bioequivalence study of Luphere Depot Injection 30 mg in adult male subjects with metastatic prostate cancer

Not Applicable

• Conditions: Health Condition 1: C61- Malignant neoplasm of prostate

• Registration Number: CTRI/2019/07/020258
• Lead Sponsor: Daewoong Pharmaceutical Co Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Must be able to provide voluntary informed consent and to follow protocol requirements

2.Male subjects aged 18 to 75 years (both inclusive).

3.Patients having body mass index (BMI) between 18.00 to 30.00 kg / m2 (both inclusive).

4.Males with histologically/cytologically confirmed carcinoma of prostate

5.Newly diagnosed metastatic prostate cancer patients scheduled to receive their first dose of leuprorelin as a part of their standard of care.

6.Eastern Cooperative Oncology Group (ECOG) performance status <= 2. Refer Appendix A

7.Acceptable hematology status:

a.Hemoglobin >= 9 g/dL

b.Absolute neutrophil count (ANC) >= 1500 cells/mm3

c.Platelet count >= 100,000 cells/mm3

8.Acceptable liver function:

a.Alanine aminotransferase (ALT) <= 2 X ULN

b.Aspartate aminotransferase (AST) <= 2 X ULN

c.Bilirubin <= 1.2 X ULN

d.Alkaline phosphatase <=5 x ULN

9.Subjects with HbA1c <= 7 %

10.Subjects with creatinine clearance >= 60 mL/minute.

11.Subjects with life expectancy of at least 6 months at the time of enrolment.

12.Subjects who agree to use adequate male contraceptive methods while in the study.

13.No history of addiction to any recreational drug or drug dependence or alcohol addiction.

Exclusion Criteria

1.Known hypersensitivity or contraindication to GnRH, GnRH agonist or to any of the components of investigational product.

2.Prior orchidectomy, hypophysectomy or adrenalectomy

3.Clinical indication of urinary tract obstruction

4.History of any major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.

5.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.)

6.Known CNS metastasis.

7.Surgical or other non-healing wounds.

8.Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).

9.Subjects with positive urine screen for Drugs of Abuse.

10.Subjects with positive Alcohol breath test.

11.Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day

12.History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).

13.Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.

14.Donation of >= 350 mL blood within 90 days prior to receiving the first dose of investigational product for the current study.

15.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.

16.Any other condition(s) which could significantly interfere with Protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the bioavailability of Luphere Depot Injecton 30mg of Daewoong Pharmaceutical Co. Ltd with LUCRIN Depot (leuprorelin acetate for depot suspension) 30 mg of AbbVie Pty Ltd Australia in adult male subjects with metastatic prostate cancer undergoing initial therapy under fasting conditions.Timepoint: Day01:Pre-dose blood sample(00.00) within 30 minutes prior to dosing,( 00.25hr,00.50 hr,01.0 hr,01.50hr,02.00hr,02.50hr(± 05 minutes)),(03.00 hr,04.00 hr,06.00 hr,08.00hr,12.00hr(± 10 minutes)),Day02:24.00hr(± 10 minutes),(Day 03:48.00hr, Day 07:144.00hr,Day 14:312.00hr,Day 21:480.00hr,Day 28:648.00hr,Day35:816.00 hr(± 4 hr)),(Day42:984.00hr, Day 56:1320.00hr,Day70:1656.00 hr,Day84:1992.00hr,Day98:2328.00 hr,Day:112 2664.00 hr,Day126:3000.00 hr(± 1 Day)) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To monitor the adverse events and to ensure the safety of subjects.Timepoint: Day01:Pre-dose blood sample(00.00) within 30 minutes prior to dosing,( 00.25hr,00.50 hr,01.0 hr,01.50hr,02.00hr,02.50hr(± 05 minutes)),(03.00 hr,04.00 hr,06.00 hr,08.00hr,12.00hr(± 10 minutes)),Day02:24.00hr(± 10 minutes),(Day 03:48.00hr, Day 07:144.00hr,Day 14:312.00hr,Day 21:480.00hr,Day 28:648.00hr,Day35:816.00 hr(± 4 hr)),(Day42:984.00hr, Day 56:1320.00hr,Day70:1656.00 hr,Day84:1992.00hr,Day98:2328.00 hr,Day:112 2664.00 hr,Day126:3000.00 hr(± 1 Day)) <br/ ><br>