Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted 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 Fasted Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417831
• Other study ID #: 527.88
• Status: Completed
• Phase: Phase 1
• Start date: April 30, 2015
• Est. completion date: May 31, 2015

Study information

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

Clinical Trial Summary

A bio-equivalence of 2 different capsule formulations in fasted subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 31, 2015
• Est. primary completion date: May 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• tamsulosin capsules

• 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	Cmax	Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.	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.
Primary	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.	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.
Primary	(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.	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	Tmax	Time to maximum plasma concentration	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	?z	Terminal elimination rate constant in plasma (?z).; Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.	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	t1/2	Apparent terminal elimination half-life of the analyte in plasma (t1/2); Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.	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.

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