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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

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ClinicalTrials.gov Identifier: NCT01389609
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : July 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. administration. [ Time Frame: up to 48 hours ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389609


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01389609     History of Changes
Other Study ID Numbers: A0351069
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: October 7, 2011
Last Verified: October 2011

Keywords provided by Pfizer:
Bioequivalence
Orally-disintegrating Tablet

Additional relevant MeSH terms:
Doxazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs