Recent Updates
Recently added Catalysts

Doxazosin Japanese marketed IR

Phase 1

Hypertension | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Jan 29, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Doxazosin Japanese marketed IR · 1 trial · 1 indication

Phase 1 1
NCT01389609Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted ConditionHypertension
COMPLETED24 Analytics
PHASE1COMPLETED
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
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALDoxazosin 4 mg Japanese marketed IR tablet as a single oral dose under fasted conditions
BEXPERIMENTALDoxazosin 4 mg ODT with water as a single oral dose under fasted conditions
CEXPERIMENTALDoxazosin 4 mg ODT without water as a single oral dose under fasted conditions

Interventions

NameTypeDescription
Doxazosin 4 mg Japanese marketed IR tabletDRUGImmediate release tablet, 4 mg, single dose
Doxazosin 4 mg ODT with waterDRUGOrally-disintegrating Tablet , 4 mg, single dose with water
Doxazosin 4 mg ODT without waterDRUGOrally-disintegrating Tablet , 4 mg, single dose without water
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 supin...

Countries:Japan
Unlock Eligibility Criteria

Frequently asked questions about Doxazosin Japanese marketed IR

What is Doxazosin Japanese marketed IR used for?

Doxazosin Japanese marketed IR is a small molecule being studied for the treatment of hypertension. It is an immediate release formulation of doxazosin, developed by Pfizer, Inc. The drug is currently in Phase 1 clinical development for this cardiovascular condition.

Who makes Doxazosin Japanese marketed IR?

Doxazosin Japanese marketed IR is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is being investigated as a treatment for hypertension.

What phase is Doxazosin Japanese marketed IR in?

Doxazosin Japanese marketed IR is in Phase 1 clinical development. It is an investigational drug being studied for hypertension. A Phase 1 bioequivalence study has been completed, and the drug has not yet been approved by regulatory authorities.

What clinical trials is Doxazosin Japanese marketed IR in?

Doxazosin Japanese marketed IR has one completed clinical trial, NCT01389609. This Phase 1 study evaluated the bioequivalence of a 4 mg orally-disintegrating tablet with or without water compared to the 4 mg Japanese marketed immediate release tablet under fasted conditions. The trial enrolled 24 healthy male volunteers in Japan.

Is Doxazosin Japanese marketed IR the same as doxazosin?

Doxazosin Japanese marketed IR is a specific immediate release formulation of doxazosin, a drug used for hypertension. It is being studied as a reference product in a bioequivalence trial. The drug is developed by Pfizer, Inc. and is currently in Phase 1 clinical development.