Back to resultsDetermine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.
Primary Purpose
Prostatic Hyperplasia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
tamsulosin capsules
tamsulosin HCl
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia
Eligibility Criteria
Inclusion criteria:
Healthy male volunteers 18 years and older
Exclusion criteria:
History of hypersensitivity or allergy to the IPM 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 capsules
tamsulosin HCl capsules
Arm Description
Outcomes
Primary Outcome Measures
Cmax
Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
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).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
(AUC0-inf)
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Secondary Outcome Measures
Tmax
Time to maximum plasma concentration
λz
Terminal elimination rate constant in plasma (λz).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
t1/2
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02417831
Brief Title
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted 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 Fasted Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2015 (Actual)
Primary Completion Date
May 31, 2015 (Actual)
Study Completion Date
May 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
A bio-equivalence of 2 different capsule formulations in fasted subjects
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 capsules
Arm Type
Active Comparator
Arm Title
tamsulosin HCl capsules
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
tamsulosin capsules
Intervention Type
Drug
Intervention Name(s)
tamsulosin HCl
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
Title
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).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
Title
(AUC0-inf)
Description
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
Secondary Outcome Measure Information:
Title
Tmax
Description
Time to maximum plasma concentration
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
Title
λz
Description
Terminal elimination rate constant in plasma (λz).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
Title
t1/2
Description
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Time Frame
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 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:
Healthy male volunteers 18 years and older
Exclusion criteria:
History of hypersensitivity or allergy to the IPM 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 Fasted Male.
We'll reach out to this number within 24 hrs