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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Doxazosin 4 mg Japanese marketed IR tablet as a single oral dose under fasted conditions
Drug: Doxazosin 4 mg Japanese marketed IR tablet
Immediate release tablet, 4 mg, single dose
Experimental: B
Doxazosin 4 mg ODT with water as a single oral dose under fasted conditions
Drug: Doxazosin 4 mg ODT with water
Orally-disintegrating Tablet , 4 mg, single dose with water
Experimental: C
Doxazosin 4 mg ODT without water as a single oral dose under fasted conditions
Drug: Doxazosin 4 mg ODT without water
Orally-disintegrating Tablet , 4 mg, single dose without water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
up to 48 hours
administration.
Time Frame: up to 48 hours
up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0351069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Doxazosin 4 mg Japanese marketed IR tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe