Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules
Status:
Recruiting
Trial end date:
2022-01-23
Target enrollment:
Participant gender:
Summary
Prazosin hydrochloride (HCl) is an oral anti-hypertensive indicated for the treatment of
primary and secondary hypertension and heart failure. Pfizer Inc. is the marketing
authorization holder for prazosin HCl oral capsules and intended to transfer drug product
manufacturing operations from Pfizer, Barceloneta Puerto Rico to Pfizer Pharmaceutical,
Ascoli, Italy. To support the manufacturer site transfer and process changes, this
bioequivalence (BE) study is being conducted.
This study will be a 2 Cohort, open-label, randomized, single dose study in healthy adult
male and/or female participants. Cohort 1 will be crossover with 3 treatments, 3 periods, 6
sequences. Cohort 2 will be crossover with 2 treatments, 2 periods, 2 sequences. Primary
objective of this study is demonstrate bioequivalence between prazosin HCl 1, 2 and 5 mg
capsules manufactured at Ascoli versus prazosin HCl 2 and 5 mg capsules manufactured at
Barceloneta under fasting conditions in healthy adult participants. Approximately 36
participants will be enrolled in each Cohort 1 and Cohort 2.
Pharmacokinetic and statistical analysis will be performed for prazosin. Data from 2 Cohorts
will be analyzed separately. The PK parameters area under the plasma concentration-time curve
from time zero to the time of the last quantifiable concentration (AUClast), and from time
zero extrapolated to infinite time (AUCinf), maximum plasma concentration (Cmax), time to
first occurrence of Cmax (Tmax), and terminal phase elimination half-life (t½) will be
summarized descriptively by analyte and treatment.
For primary objective, bioequivalence of the Test treatment relative to Reference treatment
will be concluded if the 90% confidence intervals (CI) for the ratio of adjusted geometric
means of Test treatments relative to Reference treatment for AUCinf (if data permit), AUClast
and Cmax, fall wholly within (80%, 125%).