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

Phase 1CompletedNCT02417844

Boehringer Ingelheim34 enrolled

Overview

Two tamsulosin HClformulations will be tested in fed state

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

34

Conditions

Prostatic Hyperplasia

Interventions

tamsulosin (Astellas)DRUG

Tamsulosin HCLDRUG

Eligibility

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

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Maximum Measured Concentration (Cmax)

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

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)

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

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).

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 Outcomes

Time to Maximum Plasma Concentration (Tmax)

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

Terminal Elimination Rate Constant (λz)

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

Apparent Terminal Elimination Half-life (t1/2)

Data from ClinicalTrials.gov

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NCT02417844 - Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male. | Crick | Crick