Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fasting conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg |
|
| 2 | Active Comparator | Benicar HCT® Tablets 40 mg/25 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg | Drug |
| ||
| Benicar HCT® Tablets 40 mg/25 mg |
| Measure | Description | Time Frame |
|---|---|---|
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. | blood collections through 48 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan K Copa, Pharm. D. | PRACS Institute Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRACS Institute Ltd. | Fargo | North Dakota | 58104 | United States |
Not provided
| Label | URL |
|---|---|
| Mylan Pharmaceuticals Inc. - Clinical Trial Results | View source |
| Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use | View source |
| Recalls, Market Withdrawals and Safety Alerts |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| View source |
| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided