Trial Outcomes & Findings for Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions (NCT NCT00828321)
NCT ID: NCT00828321
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax of Ramipril.
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
|
20
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 42 Days
STARTED
|
20
|
20
|
|
Washout of 42 Days
COMPLETED
|
18
|
20
|
|
Washout of 42 Days
NOT COMPLETED
|
2
|
0
|
|
Second Intervention
STARTED
|
18
|
20
|
|
Second Intervention
COMPLETED
|
18
|
19
|
|
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.
|
|---|---|---|
|
Washout of 42 Days
Withdrawal by Subject
|
2
|
0
|
|
Second Intervention
Protocol Violation
|
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
|
|---|---|---|---|
|
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
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 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
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 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 of Ramipril.
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)of Ramipril
|
24243.26 pg/mL
Standard Deviation 10801.83
|
25646.69 pg/mL
Standard Deviation 10793.02
|
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 of Ramipril.
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)of Ramipril
|
20716.92 pg*h/mL
Standard Deviation 8241.81
|
20859.98 pg*h/mL
Standard Deviation 9796.3
|
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 for Ramipril.
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)of Ramipril.
|
21310.07 pg*h/mL
Standard Deviation 8422.26
|
21406.11 pg*h/mL
Standard Deviation 9997.76
|
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)of Ramiprilat.
|
25892.38 pg/mL
Standard Deviation 17462.37
|
26154.13 pg/mL
Standard Deviation 18380.56
|
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 72 Hours)of Ramiprilat.
|
196669.75 pg*h/mL
Standard Deviation 69676.68
|
201747.51 pg*h/mL
Standard Deviation 73592.98
|
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