Trial Outcomes & Findings for Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions (NCT NCT00829452)
NCT ID: NCT00829452
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Blood samples collected over a 72 hour period.
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Test (Ramipril) First
10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
|
Reference (Altace®) First
10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
20
|
20
|
|
First Intervention
COMPLETED
|
20
|
19
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Washout of 42 Days
STARTED
|
20
|
19
|
|
Washout of 42 Days
COMPLETED
|
20
|
18
|
|
Washout of 42 Days
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
20
|
18
|
|
Second Intervention
COMPLETED
|
20
|
17
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Test (Ramipril) First
10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
|
Reference (Altace®) First
10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
0
|
1
|
|
Washout of 42 Days
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention
Physician Decision
|
0
|
1
|
Baseline Characteristics
Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Test (Ramipril) First
n=20 Participants
10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
|
Reference (Altace®) First
n=20 Participants
10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 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
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 participants
n=5 Participants
|
13 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
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
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Ramipril)
n=37 Participants
10 mg Ramipril Capsules test product dosed in either period.
|
Reference (Altace®)
n=37 Participants
10 mg Altace® Capsules reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.
|
21887.1 pg/mL
Standard Deviation 8460.92
|
23640.37 pg/mL
Standard Deviation 10926.53
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Ramipril)
n=37 Participants
10 mg Ramipril Capsules test product dosed in either period.
|
Reference (Altace®)
n=37 Participants
10 mg Altace® Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) for Ramipril.
|
17495.08 pg*h/mL
Standard Deviation 5964.21
|
18487.79 pg*h/mL
Standard Deviation 6792.41
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Ramipril)
n=37 Participants
10 mg Ramipril Capsules test product dosed in either period.
|
Reference (Altace®)
n=37 Participants
10 mg Altace® Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) for Ramipril.
|
18124.29 pg*h/mL
Standard Deviation 6270.72
|
18859.79 pg*h/mL
Standard Deviation 6825.69
|
SECONDARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of Cmax values for the metabolite Ramiprilat.
Outcome measures
| Measure |
Test (Ramipril)
n=37 Participants
10 mg Ramipril Capsules test product dosed in either period.
|
Reference (Altace®)
n=37 Participants
10 mg Altace® Capsules reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.
|
20293.09 pg/mL
Standard Deviation 14160.29
|
19670.12 pg/mL
Standard Deviation 13834.13
|
SECONDARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUc0-72 values for the metabolite Ramiprilat.
Outcome measures
| Measure |
Test (Ramipril)
n=37 Participants
10 mg Ramipril Capsules test product dosed in either period.
|
Reference (Altace®)
n=37 Participants
10 mg Altace® Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours) for Ramiprilat.
|
164741.84 pg*h/mL
Standard Deviation 50195.92
|
168246.84 pg*h/mL
Standard Deviation 46106.74
|
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 The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER