Trial Outcomes & Findings for Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions (NCT NCT00835367)

Results Overview

Bioequivalence based on Cmax - Maximum observed concentration

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

68 participants

Primary outcome timeframe

Blood samples collected over 168 hour period

Results posted on

2024-08-21

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) dosed 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	34	34
First Intervention COMPLETED	34	34
First Intervention NOT COMPLETED	0	0
Washout STARTED	34	34
Washout COMPLETED	31	34
Washout NOT COMPLETED	3	0
Second Intervention STARTED	31	34
Second Intervention COMPLETED	30	33
Second Intervention NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Amlodipine Benazepril (Test) First Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed 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
Washout Adverse Event	2	0
Washout Withdrawal by Subject	1	0
Second Intervention Adverse Event	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amlodipine Benazepril (Test) First n=34 Participants Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period	Lotrel® (Reference) First n=34 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=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=99 Participants	32 Participants n=107 Participants	64 Participants n=206 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	6 Participants n=107 Participants	14 Participants n=206 Participants
Sex: Female, Male Male	26 Participants n=99 Participants	28 Participants n=107 Participants	54 Participants n=206 Participants
Race/Ethnicity, Customized Caucasian	28 Participants n=99 Participants	27 Participants n=107 Participants	55 Participants n=206 Participants
Race/Ethnicity, Customized American Hispanic	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Race/Ethnicity, Customized Black	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 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=62 Participants Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period	Lotrel® n=62 Participants Lotrel® 10/20 mg capsule (reference) dosed in either period
Cmax - Amlodipine	5621.36 pg/mL Standard Deviation 1079.24	5536.86 pg/mL Standard Deviation 1183.43

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=62 Participants Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period	Lotrel® n=62 Participants Lotrel® 10/20 mg capsule (reference) dosed in either period
AUC0-inf - Amlodipine	370735.08 pg*h/mL Standard Deviation 105920.24	363080.38 pg*h/mL Standard Deviation 111778.14

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)