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
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Doxazosin 4 mg Japanese marketed IR tablet (Drug); Doxazosin 4 mg ODT with water (Drug); Doxazosin 4 mg ODT without water (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Cmax and AUCt of doxazosin 4 mg ODT with water compared to doxazosin 4 mg Japanese marketed IR tablet under fasted conditions.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 administration.
Eligibility
Minimum age: 20 Years.
Maximum age: 55 Years.
Gender(s): Male.
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.
Locations and Contacts
Pfizer Investigational Site, Shinjuku-ku, Tokyo, Japan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: July 2011
Last updated: October 5, 2011
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