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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389609
• Other study ID #: A0351069
• Status: Completed
• Phase: Phase 1
• Start date: July 2011
• Est. completion date: August 2011

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Doxazosin 4 mg Japanese marketed IR tablet
Immediate release tablet, 4 mg, single dose
• Doxazosin 4 mg ODT with water
Orally-disintegrating Tablet , 4 mg, single dose with water
• Doxazosin 4 mg ODT without water
Orally-disintegrating Tablet , 4 mg, single dose without water

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Shinjuku-ku	Tokyo

Sponsors (1)

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

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	administration.		up to 48 hours

External Links

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