Trial Outcomes & Findings for Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting Conditions (NCT NCT00834067)
NCT ID: NCT00834067
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 Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
30
|
30
|
|
First Intervention
COMPLETED
|
30
|
30
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 21 Days
STARTED
|
30
|
30
|
|
Washout of 21 Days
COMPLETED
|
30
|
29
|
|
Washout of 21 Days
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
30
|
29
|
|
Second Intervention
COMPLETED
|
30
|
29
|
|
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 Tablets test product dosed in the second period.
|
|---|---|---|
|
Washout of 21 Days
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-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=30 Participants
15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
|
Total
n=60 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
|
30 Participants
n=107 Participants
|
60 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
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 participants
n=99 Participants
|
2 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
22 participants
n=99 Participants
|
25 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
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
|
30 participants
n=107 Participants
|
60 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=59 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=59 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.
|
14.487 ng/mL
Standard Deviation 6.706
|
14.885 ng/mL
Standard Deviation 6.018
|
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=59 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=59 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.
|
35.412 ng*h/mL
Standard Deviation 41.756
|
34.917 ng*h/mL
Standard Deviation 47.077
|
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=59 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=59 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.
|
36.651 ng*h/mL
Standard Deviation 43.262
|
35.74 ng*h/mL
Standard Deviation 47.957
|
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=59 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=59 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.
|
150.225 ng/mL
Standard Deviation 42.664
|
148.39 ng/mL
Standard Deviation 39.83
|
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=59 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=59 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.
|
1105.63 ng*h/mL
Standard Deviation 260.669
|
1100.5 ng*h/mL
Standard Deviation 271.834
|
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=59 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=59 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.
|
1115.905 ng*h/mL
Standard Deviation 259.765
|
1108.329 ng*h/mL
Standard Deviation 271.82
|
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=59 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=59 Participants
15/25 mg Uniretic® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.
|
5.512 ng/mL
Standard Deviation 3.241
|
5.13 ng/mL
Standard Deviation 2.788
|
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=59 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=59 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.
|
215.654 ng*h/mL
Standard Deviation 61.545
|
214.286 ng*h/mL
Standard Deviation 69.726
|
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=59 Participants
15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
|
Reference (Uniretic®)
n=59 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.
|
376.814 ng*h/mL
Standard Deviation 144.282
|
379.994 ng*h/mL
Standard Deviation 184.852
|
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