Trial Outcomes & Findings for Amlodipine 10 mg Tablets Under Fasting Conditions (NCT NCT00841542)
NCT ID: NCT00841542
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
|
13
|
14
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
13
|
14
|
|
Period 2
COMPLETED
|
13
|
14
|
|
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
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
Baseline Characteristics
Amlodipine 10 mg Tablets Under Fasting 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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mulatto
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
28 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 168 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Amlodipine
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
|
6.16 ng/mL
Standard Deviation 1.64
|
6.29 ng/mL
Standard Deviation 1.81
|
PRIMARY outcome
Timeframe: Blood samples collected over 168 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Amlodipine
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)
|
323.27 ng*h/mL
Standard Deviation 106.34
|
326.49 ng*h/mL
Standard Deviation 107.40
|
PRIMARY outcome
Timeframe: Blood samples collected over 168 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Amlodipine
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)
|
299.84 ng*h/mL
Standard Deviation 90.80
|
302.52 ng*h/mL
Standard Deviation 95.13
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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