Trial Outcomes & Findings for Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions (NCT NCT00834977)

Results Overview

Bioequivalence based on Cmax - Maximum observed concentration

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

48 participants

Primary outcome timeframe

Blood samples collected over 168 hour period

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Amlodipine Benazepril (Test) First Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period	Lotrel® (Reference) First Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
First Intervention STARTED	24	24
First Intervention COMPLETED	24	24
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	24	24
Second Intervention COMPLETED	24	24
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amlodipine Benazepril (Test) First n=24 Participants Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period	Lotrel® (Reference) First n=24 Participants Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Canada	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.

Bioequivalence based on Cmax - Maximum observed concentration

Outcome measures

Outcome measures
Measure	Amlodipine Benazepril n=47 Participants Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period	Lotrel® n=47 Participants Lotrel® 10/20 mg capsule (reference) dosed in either period
Cmax - Amlodipine	6299.49 pg/mL Standard Deviation 1917.69	6185.06 pg/mL Standard Deviation 1697.24

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.

Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)

Outcome measures

Outcome measures
Measure	Amlodipine Benazepril n=47 Participants Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period	Lotrel® n=47 Participants Lotrel® 10/20 mg capsule (reference) dosed in either period
AUC0-inf - Amlodipine	365612.90 pg*h/mL Standard Deviation 143713.73	366523.24 pg*h/mL Standard Deviation 140268.40

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.

Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)