Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.24 enrolled

Overview

To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Doxazosin 4 mg Japanese marketed IR tabletDRUG

Immediate release tablet, 4 mg, single dose

Doxazosin 4 mg ODT with waterDRUG

Orally-disintegrating Tablet , 4 mg, single dose with water

Doxazosin 4 mg ODT without waterDRUG

Orally-disintegrating Tablet , 4 mg, single dose without water

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese healthy male subjects Exclusion Criteria: * Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in SBP, a ≥10 mm Hg reduction in DBP and/or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.

Locations (1)

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Peak plasma concentration (Cmax) and AUC from zero to the last sampling point (AUCt) of doxazosin 4 mg Orally Disintegrating Tablet (ODT) without water compared to doxazosin 4 mg Japanese marketed Immediate Release (IR) tablet under fasted conditions

Time frame: up to 48 hours

Secondary Outcomes

Cmax and AUCt of doxazosin 4 mg ODT with water compared to doxazosin 4 mg Japanese marketed IR tablet under fasted conditions.

Time frame: up to 48 hours

Other Pharmacokinetic (PK) parameters (Tmax, AUC from zero to infinity (AUCinf), AUC from zero to the last measurable point (AUClast), elimination rate constant (Kel), t½, and mean residence time (MRT) of doxazosin under all forms of

Time frame: up to 48 hours

administration.

Time frame: up to 48 hours

Data from ClinicalTrials.gov

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