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Prazosin

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 14, 2026

Target and mechanism

ModalitySmall molecule

Also known as Prazosin HCl 2mg, Prazosin HCl

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment69

FDA Designations

No designations recorded

Clinical trial landscape

Prazosin · 2 trials · 3 indications

Phase 1 2
NCT07231978A Study to Learn How Different Forms of the Study Medicine Called Prazosin Are Taken up Into the Blood in Healthy AdultsHealthy
COMPLETED69 Analytics
NCT04967443Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride CapsulesHypertension
COMPLETED72 Analytics
PHASE1COMPLETED
A Study to Learn How Different Forms of the Study Medicine Called Prazosin Are Taken up Into the Blood in Healthy Adults
Healthy
NCT0723197869
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PHASE1COMPLETED
Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules
Hypertension
NCT0496744372
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Study Endpoints

Primary Endpoints

Pharmacokinetics: Area under the plasma concentration (AUC) of prazosin
Predose, upto 5 weeks
PK: Maximum plasma concentration (Cmax) of prazosin
Predose, upto 5 weeks
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Maximum Observed Plasma Concentration (Cmax) of Prazosin
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period

Secondary Endpoints

Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Through study completion, approximately 10 weeks
Number of Participants With Clinical Laboratory Abnormalities
Through study completion, approximately 10 weeks
Number of participants with change from baseline in physical examinations
Through study completion, approximately 10 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALParticipants will receive a single dose of Prazosin HCl in 4 treatments.
Cohort 2EXPERIMENTALParticipants will receive a single dose of Prazosin HCl in 2 treatments.
Prazosin Hydrochloride (HCL) 2 milligram (mg) capsule Barceloneta siteACTIVE_COMPARATOROne 2 mg capsule manufactured at the current site, Barceloneta
Prazosin HCL 2 mg capsule Ascoli siteEXPERIMENTALOne 2 mg capsule manufactured at the proposed site (Ascoli)
Prazosin HCL 1 mg capsule Ascoli siteEXPERIMENTALTwo 1 mg capsule manufactured at the proposed site, Ascoli
Prazosin HCL 5 mg capsule Barceloneta siteACTIVE_COMPARATOROne 5 mg capsule manufactured at the current site, Barceloneta
Prazosin HCL 1 x 5 mg capsule Ascoli siteACTIVE_COMPARATOROne 5 mg capsule manufactured at the proposed site, Ascoli

Interventions

NameTypeDescription
Prazosin HClDRUGAdministered Orally; available in capsule form
Prazosin HCl 2mgDRUGPrazosin HCL 1 X 2 mg capsule.
Prazosin HCl 1 mgDRUGPrazosin HCl 2 X 1 mg capsule.
Prazosin HCl 5 mgDRUGPrazosin HCL 1 X 5 mg capsule.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion: * Male and female participants, 18 years of age or older and who are overtly healthy as determined by medical evaluation * Willing to comply with all study procedures * BMI of 16-32 kg/m2; and a total body weight \>50 kg (110 lb) * Capable of giving signed informed consent Exclusion: *...

Countries:BelgiumUnited States
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