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The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 50 mg under fasting conditions
An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 50 mg of Dr. Reddy's Laboratories Limited,under fasting conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoprolol Succinate ER Tablets, 50 mg | Experimental | Metoprolol Succinate ER Tablets, 50 mg of Dr.Reddy's Laboratories Ltd |
|
| TOPROL-XL ER Tablets 50 mg | Active Comparator | TOPROL-XL ER Tablets 50 mg of AstraZeneca |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol Succinate | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve (AUC) | Pre-dose (0.00) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose. |
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Inclusion Criteria:
Subjects were selected based on the following inclusion criteria:
Exclusion Criteria:
The subjects were excluded based on the following criteria during screening and during the study:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. P. Vijaya Lakshmi, Clinical Investigator | Bioserve Clinical Research Private Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioserve Clinical Research Private Limited | Hyderabad | Andhra Pradesh | 500 037 | India |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |