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The objective of this study is to compare the relative bioavailability of Moexipril HCl/hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy, adult non-smoking subjects under fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moexipril HCl/hydrochlorothiazide 15/25 mg tablets | Drug | 1 x 15/25 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril. | Bioequivalence based on Cmax. | Blood samples collected over a 192 hour period. |
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril. | Bioequivalence based on AUC0-t. | Blood samples collected over a 192 hour period. |
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril. | Bioequivalence based on AUC0-inf. | Blood samples collected over a 192 hour period. |
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide. | Bioequivalence based on Cmax. | Blood samples collected over a 192 hour period. |
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide. | Bioequivalence based on AUC0-t. | Blood samples collected over a 192 hour period. |
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide. | Bioequivalence based on AUC0-inf. | Blood samples collected over a 192 hour period. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat. | Informational comparison of Cmax values for the metabolite Moexiprilat. | Blood samples collected over a 192 hour period. |
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Herrmann, M.D.; Ph. D. | Gateway Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gateway Medical Research, Inc. | Saint Charles | Missouri | 63301 | United States | ||
| Bioassay Laboratory, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout of 21 Days |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Reference (Uniretic®) First |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril. | Bioequivalence based on Cmax. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng/mL | Blood samples collected over a 192 hour period. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Biopharmaceutics | TEVA Pharmaceuticals, USA | 1-866-384-5525 | clinicaltrialqueries@tevausa.com |
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| UNIRETIC® 15/25 mg tablets |
| Drug |
1 x 15/25 mg |
|
Informational comparison of AUC0-t values for the metabolite Moexiprilat. |
| Blood samples collected over a 192 hour period. |
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat. | Informational comparison of AUC0-inf values for the metabolite Moexiprilat. | Blood samples collected over a 192 hour period. |
| Houston |
| Texas |
| 77099 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril. | Bioequivalence based on AUC0-t. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 192 hour period. |
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| Primary | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril. | Bioequivalence based on AUC0-inf. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 192 hour period. |
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| Primary | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide. | Bioequivalence based on Cmax. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng/mL | Blood samples collected over a 192 hour period. |
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| Primary | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide. | Bioequivalence based on AUC0-t. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 192 hour period. |
|
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|
| Primary | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide. | Bioequivalence based on AUC0-inf. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 192 hour period. |
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| Secondary | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat. | Informational comparison of Cmax values for the metabolite Moexiprilat. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng/mL | Blood samples collected over a 192 hour period. |
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| Secondary | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat. | Informational comparison of AUC0-t values for the metabolite Moexiprilat. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 192 hour period. |
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| Secondary | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat. | Informational comparison of AUC0-inf values for the metabolite Moexiprilat. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 192 hour period. |
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The Principal Investigator is not permitted to discuss or publish trial results.