Trial Outcomes & Findings for Ramipril 10 mg Capsule in Healthy Subjects Under Fed Conditions (NCT NCT00829530)
NCT ID: NCT00829530
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
|
18
|
|
First Intervention
NOT COMPLETED
|
0
|
2
|
|
Washout of 42 Days
STARTED
|
20
|
18
|
|
Washout of 42 Days
COMPLETED
|
20
|
18
|
|
Washout of 42 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
20
|
18
|
|
Second Intervention
COMPLETED
|
19
|
18
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
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
Adverse Event
|
0
|
1
|
|
First Intervention
Intolerance to Venopuncture
|
0
|
1
|
|
Second Intervention
Intolerance to Venopuncture
|
1
|
0
|
Baseline Characteristics
Ramipril 10 mg Capsule in Healthy Subjects Under Fed 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
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 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.
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.
|
7590.97 pg/mL
Standard Deviation 3350.28
|
8490.5 pg/mL
Standard Deviation 3327.88
|
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.
|
20536.35 pg*h/mL
Standard Deviation 12433.08
|
21415.4 pg*h/mL
Standard Deviation 11779.1
|
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.
|
20879.45 pg*h/mL
Standard Deviation 12517.96
|
21732.68 pg*h/mL
Standard Deviation 11935.93
|
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.
|
14500.51 pg/mL
Standard Deviation 10316.6
|
14843.1 pg/mL
Standard Deviation 12576.25
|
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.
|
166857.53 pg*h/mL
Standard Deviation 55803.82
|
166439.69 pg*h/mL
Standard Deviation 57195.09
|
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