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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Doxazosin 4 mg Japanese marketed IR tablet
* Drug: Doxazosin 4 mg ODT with water
* Drug: Doxazosin 4 mg ODT without water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Doxazosin 4 mg Japanese marketed IR tablet as a single oral dose under fasted conditions | Drug: Doxazosin 4 mg Japanese marketed IR tablet<br>* Immediate release tablet, 4 mg, single dose<br>|
| Experimental: B<br>Doxazosin 4 mg ODT with water as a single oral dose under fasted conditions | Drug: Doxazosin 4 mg ODT with water<br>* Orally-disintegrating Tablet , 4 mg, single dose with water<br>|
| Experimental: C<br>Doxazosin 4 mg ODT without water as a single oral dose under fasted conditions | Drug: Doxazosin 4 mg ODT without water<br>* Orally-disintegrating Tablet , 4 mg, single dose without water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| administration. |  | up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Orally-disintegrating Tablet