Status:
UNKNOWN
To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers
Lead Sponsor:
Peptron, Inc.
Conditions:
Prostate Cancer
Eligibility:
FEMALE
19+ years
Phase:
PHASE1
Brief Summary
The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers
Detailed Description
The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers
Eligibility Criteria
Inclusion
- A healthy woman who is over 19 years of age and has been certified obstetrically with menopause, at the time of screening.
- Subjects weighing over 50 kg with BMI between 18 and 30 kg/m2 (inclusive) at screening visit.
Exclusion
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Those whose plasma AST and ALT exceed 2 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
- Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
Key Trial Info
Start Date :
March 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04783636
Start Date
March 11 2021
End Date
July 20 2021
Last Update
March 17 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.