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

Viatris

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Doxazosin 4 mg Japanese marketed IR tablet; Drug: Doxazosin 4 mg ODT with water; Drug: Doxazosin 4 mg ODT without water

Study type: Interventional

Funder types: Industry

Identifiers

NCT01389609

A0351069

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

A

Experimental group

Description:

Doxazosin 4 mg Japanese marketed IR tablet as a single oral dose under fasted conditions

Treatment:

Drug: Doxazosin 4 mg Japanese marketed IR tablet

B

Experimental group

Description:

Doxazosin 4 mg ODT with water as a single oral dose under fasted conditions

Treatment:

Drug: Doxazosin 4 mg ODT with water

C

Experimental group

Description:

Doxazosin 4 mg ODT without water as a single oral dose under fasted conditions

Treatment:

Drug: Doxazosin 4 mg ODT without water