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

NCT01389609 Phase 1 COMPLETED

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

Details

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2011-07
Completion	2011-08

Conditions

• Hypertension

Interventions

• Doxazosin 4 mg Japanese marketed IR tablet
• Doxazosin 4 mg ODT with water
• Doxazosin 4 mg ODT without water

Primary outcomes

• 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

Countries

Japan