Comparison of a Novel Leuprolide With Market Leuprolide

Last updated: September 5, 2018
Sponsor: Lee's Pharmaceutical Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Treatment

N/A

Clinical Study ID

NCT03662958
ZK-LUT-201802
  • Ages 18-40
  • Male
  • Accepts Healthy Volunteers

Study Summary

This is a single dose, randomized, single blind, parallel group study to evaluate the testosterone suppressive effect in healthy male volunteers of a novel leuprolide acetate 3.75mg depot vs market reference leuprolide acetate 3.75mg depot. The safety, tolerability and the pharmacokinetic properties of the investigational drug and the control drug will also be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males of 18-40 years old (inclusive). The age difference of subjects within andbetween groups should be less than 10 years, at the time of screening.

  2. Body weight of at least 50kg. BMI to be 19-24 kg/m2 (inclusive).

  3. Able to comprehend the full nature and purpose of the study, including potential risksand side effects; able to cooperate with investigators and to comply with therequirements of the study

  4. Signed informed consent form prior to any screening procedures

Exclusion

Exclusion Criteria:

  1. Clinically significant and relevant history of cardiovascular, hepatic, renal,hematologic, endocrine, respiratory, neurological diseases or acute/chronic diseasesof the digestive tract.

  2. History of hypersensitivity towards leuprolide, synthetic LHRH or LHRH derivatives orany excipients of the study formulation.

  3. Abnormal and clinically significant 12-lead ECG

  4. Abnormal and clinically significant laboratory assessments

  5. Blood donation or blood loss greater than or equal to 400mL within 3 months prior toscreening

  6. Participation of clinical trials within 3 months prior to screening

  7. Use of any drugs within 2 weeks prior to screening

  8. History of drug abuse within 1 year prior to screening

  9. History of alcohol abuse within 1 years prior to screening

  10. History of tobacco smoking (more than 5 cigarette per day) within 1 year prior toscreening

  11. Abnormal testosterone level at screening (not in the range of 168-781ng/dL)

  12. Dermatitis or skin anomalies that might affect the administration area and thesurroundings

  13. Subject or his partner not willing to adopt appropriate contraceptive measures

  14. Subjects have a history of depressive illness or sexual dysfunction;

  15. Subjects that the investigator deems unsuitable to be enrolled

  16. Subject not willing to cooperate with the investigators.

Study Design

Total Participants: 48
Study Start date:
August 01, 2018
Estimated Completion Date:
December 31, 2018

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui
    China

    Active - Recruiting

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