Bioequivalence study of two injectable sustained release formulations of Triptorelin (Decatrip® and Dipherelin®) in Patients with prostate cancer
Not Applicable
Recruiting
- Conditions
- Triptorelin, Bioequivalent, Pharmacokinetics.Malignant neoplasm of prostate
- Registration Number
- IRCT20130603013572N8
- Lead Sponsor
- Pooyesh Darou Biopharmaceuticals company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
Patients with Prostate Cancer
Availability of the patient for the entire study period and show willingness to adhere to study requirements
Able to give written consent
Exclusion Criteria
History of hypersensitivity to the study drug
History of previous chemotherapy
Renal (serum creatinine twice normal) and hepatic failure (AST and ALT three times normal)
Administration of corticosteroids except for topical use
Donation of blood or plasma thirty days before the first day of this study
Vaccination one month before the first day of the study
Participation in a clinical trial one month before the first day of the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of drug concentration in blood serum. Timepoint: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration. Method of measurement: Triptorelin ELISA Kit.
- Secondary Outcome Measures
Name Time Method Time to peak drug concentration. Timepoint: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration. Method of measurement: observational.;Maximum drug concentration. Timepoint: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration. Method of measurement: observational.;Area under the concentration–time curves. Timepoint: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration. Method of measurement: linear trapezoidal method.