Trial Outcomes & Findings for Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules (NCT NCT04967443)
NCT ID: NCT04967443
Last Updated: 2024-07-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
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
Results posted on
2024-07-12
Participant Flow
A total of 72 participants were enrolled in the study and both cohorts (2 cohorts in total) enrolled 36 particpants.
Participant milestones
| Measure |
Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 2x1 mg (Ascoli)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Ascoli)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 2x1 mg (Ascoli)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 1x2 mg (Ascoli)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x5 mg (Barceloneta) => Prazosin HCL 1x5 mg (Ascoli)
Cohort 2, Prazosin HCl were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x5 mg (Ascoli) => Prazosin HCL 1x5 mg (Barceloneta)
Cohort 2, Prazosin HCl were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
|---|---|---|---|---|---|---|---|---|
|
Screening
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
18
|
18
|
|
Screening
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
18
|
18
|
|
Screening
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open Label Treatment
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
18
|
18
|
|
Open Label Treatment
COMPLETED
|
5
|
5
|
5
|
5
|
6
|
5
|
16
|
15
|
|
Open Label Treatment
NOT COMPLETED
|
1
|
1
|
1
|
1
|
0
|
1
|
2
|
3
|
|
Follow-Up
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
18
|
18
|
|
Follow-Up
COMPLETED
|
5
|
5
|
5
|
4
|
6
|
5
|
16
|
15
|
|
Follow-Up
NOT COMPLETED
|
1
|
1
|
1
|
2
|
0
|
1
|
2
|
3
|
Reasons for withdrawal
| Measure |
Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 2x1 mg (Ascoli)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Ascoli)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 2x1 mg (Ascoli)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 1x2 mg (Ascoli)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta)
Cohort 1, Prazosin HCL were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x5 mg (Barceloneta) => Prazosin HCL 1x5 mg (Ascoli)
Cohort 2, Prazosin HCl were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
Prazosin HCL 1x5 mg (Ascoli) => Prazosin HCL 1x5 mg (Barceloneta)
Cohort 2, Prazosin HCl were given to participants under fasted conditions. There's an at least 7-day washout period between treatment periods.
|
|---|---|---|---|---|---|---|---|---|
|
Open Label Treatment
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open Label Treatment
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Open Label Treatment
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
1
|
2
|
3
|
|
Follow-Up
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-Up
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Follow-Up
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
1
|
2
|
3
|
Baseline Characteristics
Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules
Baseline characteristics by cohort
| Measure |
Cohort 1: Male
n=24 Participants
Male participants enrolled to the cohort 1 of the study.
|
Cohort 1: Female
n=12 Participants
Female participants enrolled to the cohort 1 of the study.
|
Cohort 2: Male
n=20 Participants
Male participants enrolled to the cohort 2 of the study.
|
Cohort 2: Female
n=16 Participants
Female participants enrolled to the cohort 2 of the study.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
18-44 years
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Age, Customized
45-64 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Age, Customized
≥65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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 periodPopulation: The AUClast analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Prazosin HCL 1x2 mg (Barceloneta)
n=34 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x2 mg (Ascoli)
n=33 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 2x1 mg (Ascoli)
n=32 Participants
Cohort 1, Prazosin HCl 1 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Barceloneta)
n=33 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Ascoli)
n=34 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin
|
85.77 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
88.37 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
92.39 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
192.3 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 147
|
252.2 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: 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 periodPopulation: The Cmax analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Prazosin HCL 1x2 mg (Barceloneta)
n=34 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x2 mg (Ascoli)
n=33 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 2x1 mg (Ascoli)
n=33 Participants
Cohort 1, Prazosin HCl 1 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Barceloneta)
n=33 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Ascoli)
n=34 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Prazosin
|
14.82 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
17.04 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
19.20 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
30.91 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 143
|
38.69 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 132
|
SECONDARY outcome
Timeframe: 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 periodPopulation: The AUCinf analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
Outcome measures
| Measure |
Prazosin HCL 1x2 mg (Barceloneta)
n=31 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x2 mg (Ascoli)
n=32 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 2x1 mg (Ascoli)
n=31 Participants
Cohort 1, Prazosin HCl 1 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Barceloneta)
n=32 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Ascoli)
n=33 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin
|
89.10 ng*hr/mL
Geometric Coefficient of Variation 33
|
90.28 ng*hr/mL
Geometric Coefficient of Variation 31
|
93.01 ng*hr/mL
Geometric Coefficient of Variation 31
|
236.7 ng*hr/mL
Geometric Coefficient of Variation 37
|
259.0 ng*hr/mL
Geometric Coefficient of Variation 37
|
SECONDARY outcome
Timeframe: 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 periodPopulation: The Tmax analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
Outcome measures
| Measure |
Prazosin HCL 1x2 mg (Barceloneta)
n=33 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x2 mg (Ascoli)
n=33 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 2x1 mg (Ascoli)
n=33 Participants
Cohort 1, Prazosin HCl 1 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Barceloneta)
n=33 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Ascoli)
n=34 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin
|
2.00 hr
Interval 0.75 to 6.03
|
2.00 hr
Interval 0.5 to 4.0
|
1.50 hr
Interval 0.5 to 3.5
|
2.50 hr
Interval 1.0 to 8.03
|
2.00 hr
Interval 0.5 to 8.0
|
SECONDARY outcome
Timeframe: 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 periodPopulation: The t1/2 analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
Plasma terminal elimination half-life of Prazosin was measured.
Outcome measures
| Measure |
Prazosin HCL 1x2 mg (Barceloneta)
n=31 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x2 mg (Ascoli)
n=32 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 2x1 mg (Ascoli)
n=31 Participants
Cohort 1, Prazosin HCl 1 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Barceloneta)
n=32 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Ascoli)
n=33 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
|---|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2) of Prazosin
|
5.330 hr
Standard Deviation 1.2494
|
5.236 hr
Standard Deviation 1.0565
|
5.022 hr
Standard Deviation 1.1691
|
4.676 hr
Standard Deviation 1.1422
|
4.775 hr
Standard Deviation 1.1594
|
SECONDARY outcome
Timeframe: Time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant.
Outcome measures
| Measure |
Prazosin HCL 1x2 mg (Barceloneta)
n=34 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x2 mg (Ascoli)
n=33 Participants
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 2x1 mg (Ascoli)
n=33 Participants
Cohort 1, Prazosin HCl 1 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Barceloneta)
n=33 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Ascoli)
n=34 Participants
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) According to Seriousness
Participants with non-serious AEs (all-causality)
|
10 Participants
|
5 Participants
|
6 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (AEs) According to Seriousness
Participants with non-serious AEs (treatment-related)
|
9 Participants
|
4 Participants
|
5 Participants
|
16 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (AEs) According to Seriousness
Participants with SAEs (all-causality)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) According to Seriousness
Participants with SAEs (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Prazosin HCL 1x2 mg (Barceloneta)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
Prazosin HCL 1x2 mg (Ascoli)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Prazosin HCL 2x1 mg (Ascoli)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Prazosin HCL 1x5 mg (Barceloneta)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Prazosin HCL 1x5 mg (Ascoli)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prazosin HCL 1x2 mg (Barceloneta)
n=34 participants at risk
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x2 mg (Ascoli)
n=33 participants at risk
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 2x1 mg (Ascoli)
n=33 participants at risk
Cohort 1, Prazosin HCl 1 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Barceloneta)
n=33 participants at risk
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Ascoli)
n=34 participants at risk
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.9%
1/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
Other adverse events
| Measure |
Prazosin HCL 1x2 mg (Barceloneta)
n=34 participants at risk
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x2 mg (Ascoli)
n=33 participants at risk
Cohort 1, Prazosin HCl 2 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 2x1 mg (Ascoli)
n=33 participants at risk
Cohort 1, Prazosin HCl 1 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Barceloneta)
n=33 participants at risk
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Barceloneta, Puerto Rico, were given to participants under fasted conditions.
|
Prazosin HCL 1x5 mg (Ascoli)
n=34 participants at risk
Cohort 2, Prazosin HCl 5 mg capsules, manufactured at Pfizer Pharmaceutical, Ascoli, Italy, were given to participants under fasted conditions.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
3.0%
1/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
3.0%
1/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
21.2%
7/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
26.5%
9/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
6.1%
2/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
6.1%
2/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
9.1%
3/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
14.7%
5/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
|
Vascular disorders
Orthostatic hypotension
|
11.8%
4/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
3.0%
1/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
6.1%
2/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
9.1%
3/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
5.9%
2/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
3.0%
1/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
11.8%
4/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
27.3%
9/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
20.6%
7/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
0.00%
0/33 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
5.9%
2/34 • Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
All participants were included in adverse event monitoring whether they received study treatment or not, and for the AE reporting, AEs (all-cause mortality, serious adverse events, other adverse events) were reported by study treatments that the participants received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER