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

Phase 1CompletedNCT02417831

Boehringer Ingelheim34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

34

Conditions

Prostatic Hyperplasia

Interventions

tamsulosin capsulesDRUG

tamsulosin HClDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cmax

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.

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.

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.

(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.

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 Outcomes

Tmax

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.

λz

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.

t1/2

Data from ClinicalTrials.gov

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NCT02417831 - Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male. | Crick | Crick