Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417844
• Other study ID #: 527.89
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: April 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two tamsulosin HClformulations will be tested in fed state

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• tamsulosin (Astellas)

• Tamsulosin HCL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Measured Concentration (Cmax)	Maximum measured concentration of analyte in plasma (Cmax)	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
Primary	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)	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
Primary	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).	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	Time to Maximum Plasma Concentration (Tmax)	Time from last dosing to the maximum plasma concentration (tmax).	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	Terminal Elimination Rate Constant (?z)	Terminal elimination rate constant in plasma (?z)	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	Apparent Terminal Elimination Half-life (t1/2)	Apparent terminal elimination half-life of the analyte in plasma (t1/2)	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

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