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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Doxazosin 4 mg Japanese marketed IR tablet; Drug: Doxazosin 4 mg ODT with water; Drug: Doxazosin 4 mg ODT without water

• Registration Number: NCT01389609
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Doxazosin 4 mg Japanese marketed IR tablet	Doxazosin 4 mg Japanese marketed IR tablet as a single oral dose under fasted conditions
B	Doxazosin 4 mg ODT with water	Doxazosin 4 mg ODT with water as a single oral dose under fasted conditions
C	Doxazosin 4 mg ODT without water	Doxazosin 4 mg ODT without water as a single oral dose under fasted conditions

Primary Outcome Measures

Name	Time	Method
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	up to 48 hours

Secondary Outcome Measures

Name	Time	Method
Cmax and AUCt of doxazosin 4 mg ODT with water compared to doxazosin 4 mg Japanese marketed IR tablet under fasted conditions.	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	up to 48 hours
administration.	up to 48 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan