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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01389609
First received: July 5, 2011
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Doxazosin 4 mg Japanese marketed IR tablet
Drug: Doxazosin 4 mg ODT with water
Drug: Doxazosin 4 mg ODT without water
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • administration. [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01389609

Locations
Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01389609     History of Changes
Other Study ID Numbers: A0351069
Study First Received: July 5, 2011
Last Updated: October 5, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Bioequivalence
Orally-disintegrating Tablet

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Doxazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014