Recent Updates
Recently added Catalysts

Doxazosin Japanese marketed IR

Phase 1

Hypertension | Small molecule | Cardiovascular |Viatris Inc.|Trials 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

Doxazosin Japanese marketed IR clinical trials

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
Hypertension
NCT0138960924
Unlock 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

Competitive Landscape -Hypertension 72 trials

Top 9 of 16 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN5PHASE3Baxdrostat
Eli Lilly and CompanyLLY4PHASE3Orforglipron, Clazakizumab
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran, ALN-AGT01 RVR
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS3PHASE2QCZ484, HJB647
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
CRISPR Therapeutics AGCRSP1PHASE1CTX340
Unlock Competitive Intelligence

Explore more on BiopharmaWatch

Viatris Inc. (VTRS)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with DCompanies A to ZEvery biotech and pharma company we track