To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers
NCT ID: NCT04783636
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2021-03-11
2021-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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A
After a single administration of PT105R (leuprorelin acetate 3.75mg), a single administration of PT105 (leuprorelin acetate 3.75mg)
leuprorelin acetate 3.75mg
PT105, PT105R
B
After a single administration of PT105 (leuprorelin acetate 3.75mg), a single administration of PT105R (leuprorelin acetate 3.75mg)
leuprorelin acetate 3.75mg
PT105, PT105R
Interventions
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leuprorelin acetate 3.75mg
PT105, PT105R
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects weighing over 50 kg with BMI between 18 and 30 kg/m2 (inclusive) at screening visit.
Exclusion Criteria
* 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
19 Years
FEMALE
Yes
Sponsors
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Peptron, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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PT105-BE
Identifier Type: -
Identifier Source: org_study_id
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