Trial Outcomes & Findings for Amlodipine 10 mg Tablets Under Fed Conditions (NCT NCT00841815)

NCT ID: NCT00841815

Last Updated: 2024-08-20

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 28 participants
• Primary outcome timeframe: Blood samples collected over 168 hour period
• Results posted on: 2024-08-20

Participant Flow

Participant milestones

Measure	Amlodipine Besylate (Test) First Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period	Norvasc® (Reference) First Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
Period 1 STARTED	14	14
Period 1 COMPLETED	14	14
Period 1 NOT COMPLETED	0	0
Washout STARTED	14	14
Washout COMPLETED	14	13
Washout NOT COMPLETED	0	1
Period 2 STARTED	14	13
Period 2 COMPLETED	14	13
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Amlodipine Besylate (Test) First Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period	Norvasc® (Reference) First Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
Washout Withdrawal by Subject	0	1

Baseline Characteristics

Amlodipine 10 mg Tablets Under Fed Conditions

Baseline characteristics by cohort

Measure	Amlodipine Besylate (Test) First n=14 Participants Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period	Norvasc® (Reference) First n=14 Participants Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period	Total n=28 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	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=5 Participants	12 Participants n=7 Participants	23 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 Black	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Canada	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Amlodipine Besylate n=27 Participants Amlodipine Besylate 10 mg tablet (test) dosed in either period	Norvasc® n=27 Participants Norvasc® 10 mg tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	5.99 ng/mL Standard Deviation 1.51	6.17 ng/mL Standard Deviation 1.44

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Amlodipine Besylate n=27 Participants Amlodipine Besylate 10 mg tablet (test) dosed in either period	Norvasc® n=27 Participants Norvasc® 10 mg tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	318.95 ng*h/mL Standard Deviation 88.88	315.94 ng*h/mL Standard Deviation 94.58

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis

Bioequivalence based on AUC0-t

Outcome measures

Measure	Amlodipine Besylate n=27 Participants Amlodipine Besylate 10 mg tablet (test) dosed in either period	Norvasc® n=27 Participants Norvasc® 10 mg tablet (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	296.74 ng*h/mL Standard Deviation 81.67	295.84 ng*h/mL Standard Deviation 85.20

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER