Phase
Condition
Prostate Cancer
Treatment
N/AClinical Study ID
Ages 18-40 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
Body weight of at least 50kg. BMI to be 19-24 kg/m2 (inclusive).
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
Signed informed consent form prior to any screening procedures
Exclusion
Exclusion Criteria:
Clinically significant and relevant history of cardiovascular, hepatic, renal,hematologic, endocrine, respiratory, neurological diseases or acute/chronic diseasesof the digestive tract.
History of hypersensitivity towards leuprolide, synthetic LHRH or LHRH derivatives orany excipients of the study formulation.
Abnormal and clinically significant 12-lead ECG
Abnormal and clinically significant laboratory assessments
Blood donation or blood loss greater than or equal to 400mL within 3 months prior toscreening
Participation of clinical trials within 3 months prior to screening
Use of any drugs within 2 weeks prior to screening
History of drug abuse within 1 year prior to screening
History of alcohol abuse within 1 years prior to screening
History of tobacco smoking (more than 5 cigarette per day) within 1 year prior toscreening
Abnormal testosterone level at screening (not in the range of 168-781ng/dL)
Dermatitis or skin anomalies that might affect the administration area and thesurroundings
Subject or his partner not willing to adopt appropriate contraceptive measures
Subjects have a history of depressive illness or sexual dysfunction;
Subjects that the investigator deems unsuitable to be enrolled
Subject not willing to cooperate with the investigators.
Study Design
Connect with a study center
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
ChinaActive - Recruiting
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