Back to resultsDetermine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Primary Purpose
Prostatic Hyperplasia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
tamsulosin (Astellas)
Tamsulosin HCL
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia
Eligibility Criteria
Inclusion criteria:
Health male volunteers 18 years and older
Exclusion criteria:
History of hypersensitivity or allergy to IMP or its excipients or any related medication
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tamsulosin HCl
Tamsulosin
Arm Description
Outcomes
Primary Outcome Measures
Maximum Measured Concentration (Cmax)
Maximum measured concentration of analyte in plasma (Cmax)
Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Secondary Outcome Measures
Time to Maximum Plasma Concentration (Tmax)
Time from last dosing to the maximum plasma concentration (tmax).
Terminal Elimination Rate Constant (λz)
Terminal elimination rate constant in plasma (λz)
Apparent Terminal Elimination Half-life (t1/2)
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02417844
Brief Title
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Official Title
Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
Two tamsulosin HClformulations will be tested in fed state
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin HCl
Arm Type
Active Comparator
Arm Title
Tamsulosin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
tamsulosin (Astellas)
Intervention Type
Drug
Intervention Name(s)
Tamsulosin HCL
Primary Outcome Measure Information:
Title
Maximum Measured Concentration (Cmax)
Description
Maximum measured concentration of analyte in plasma (Cmax)
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Title
Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Title
Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)
Description
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Secondary Outcome Measure Information:
Title
Time to Maximum Plasma Concentration (Tmax)
Description
Time from last dosing to the maximum plasma concentration (tmax).
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Title
Terminal Elimination Rate Constant (λz)
Description
Terminal elimination rate constant in plasma (λz)
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Title
Apparent Terminal Elimination Half-life (t1/2)
Description
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Health male volunteers 18 years and older
Exclusion criteria:
History of hypersensitivity or allergy to IMP or its excipients or any related medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
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