Trial Outcomes & Findings for Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions (NCT NCT00835042)
NCT ID: NCT00835042
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Blood samples collected over a 192 hour period.
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Test (Moexipril HCl/HCTZ) First
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
|
Reference (Uniretic®) First
15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
30
|
28
|
|
First Intervention
COMPLETED
|
26
|
26
|
|
First Intervention
NOT COMPLETED
|
4
|
2
|
|
Washout of 21 Days
STARTED
|
26
|
26
|
|
Washout of 21 Days
COMPLETED
|
26
|
24
|
|
Washout of 21 Days
NOT COMPLETED
|
0
|
2
|
|
Second Intervention
STARTED
|
26
|
24
|
|
Second Intervention
COMPLETED
|
26
|
24
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test (Moexipril HCl/HCTZ) First
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
|
Reference (Uniretic®) First
15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
3
|
0
|
|
First Intervention
Adverse Event
|
1
|
2
|
|
Washout of 21 Days
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Test (Moexipril HCl/HCTZ) First
n=30 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
|
Reference (Uniretic®) First
n=28 Participants
15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
|
Total
n=58 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
|
30 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
58 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
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
28 participants
n=99 Participants
|
25 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
28 participants
n=107 Participants
|
58 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 192 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Moexipril HCl/HCTZ)
n=50 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=50 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.
|
31.913 ng/mL
Standard Deviation 15.761
|
34.4 ng/mL
Standard Deviation 17.4
|
PRIMARY outcome
Timeframe: Blood samples collected over a 192 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Moexipril HCl/HCTZ)
n=50 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=50 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.
|
54.517 ng*h/mL
Standard Deviation 31.582
|
53.598 ng*h/mL
Standard Deviation 28.028
|
PRIMARY outcome
Timeframe: Blood samples collected over a 192 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Moexipril HCl/HCTZ)
n=50 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=50 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.
|
55.837 ng*h/mL
Standard Deviation 31.874
|
54.593 ng*h/mL
Standard Deviation 28.107
|
PRIMARY outcome
Timeframe: Blood samples collected over a 192 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Moexipril HCl/HCTZ)
n=50 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=50 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.
|
153.602 ng/mL
Standard Deviation 54.048
|
145.088 ng/mL
Standard Deviation 43.864
|
PRIMARY outcome
Timeframe: Blood samples collected over a 192 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Moexipril HCl/HCTZ)
n=50 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=50 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.
|
992.17 ng*h/mL
Standard Deviation 309.57
|
994.093 ng*h/mL
Standard Deviation 282.294
|
PRIMARY outcome
Timeframe: Blood samples collected over a 192 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Moexipril HCl/HCTZ)
n=50 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=50 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.
|
1001.133 ng*h/mL
Standard Deviation 308.857
|
1001.548 ng*h/mL
Standard Deviation 282.322
|
SECONDARY outcome
Timeframe: Blood samples collected over a 192 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of Cmax values for the metabolite Moexiprilat.
Outcome measures
| Measure |
Test (Moexipril HCl/HCTZ)
n=50 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=50 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.
|
20.049 ng/mL
Standard Deviation 10.751
|
21.882 ng/mL
Standard Deviation 14.497
|
SECONDARY outcome
Timeframe: Blood samples collected over a 192 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUC0-t values for the metabolite Moexiprilat.
Outcome measures
| Measure |
Test (Moexipril HCl/HCTZ)
n=50 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=50 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.
|
262.231 ng*h/mL
Standard Deviation 73.413
|
264.991 ng*h/mL
Standard Deviation 75.409
|
SECONDARY outcome
Timeframe: Blood samples collected over a 192 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUC0-inf values for the metabolite Moexiprilat.
Outcome measures
| Measure |
Test (Moexipril HCl/HCTZ)
n=50 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=50 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.
|
443.448 ng*h/mL
Standard Deviation 121.714
|
427.212 ng*h/mL
Standard Deviation 136.2
|
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