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

NCT ID: NCT01389609

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

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

Group Type EXPERIMENTAL

Doxazosin 4 mg Japanese marketed IR tablet

Intervention Type DRUG

Immediate release tablet, 4 mg, single dose

B

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

Group Type EXPERIMENTAL

Doxazosin 4 mg ODT with water

Intervention Type DRUG

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

C

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

Group Type EXPERIMENTAL

Doxazosin 4 mg ODT without water

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxazosin 4 mg Japanese marketed IR tablet

Immediate release tablet, 4 mg, single dose

Intervention Type DRUG

Doxazosin 4 mg ODT with water

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

Intervention Type DRUG

Doxazosin 4 mg ODT without water

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A0351069

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.