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This study were to compare the relative bioavailability of Duloxetine HCl delayed release capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed release capsule 60 mg) in healthy, adult, human subjects under fasting conditions and to monitor safety of subjects
Open label, randomized, two period, two treatment, two sequence, crossover, balanced, single dose comparative oral bioavailability study in healthy, adult, human subjects under fasting conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine Delayed-Release Capsules, 60 mg | Experimental |
| |
| Cymbalta | Active Comparator | Cymbalta® 60 mg capsule of Eli Lilly and Company |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Duloxetine Delayed-Release Capsules 60 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve (AUC) | 1.0, 2.0,3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 11.0, 12.0, 24.0, 36.0, 48.0,60.0 and 72.0 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mayur Soni, MBBS | BA Research India Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BA Research India Ltd | Ahmedabad | Gujarat | 380 054 | India |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Cymbalta® | Drug | 60 mg capsule of Eli Lilly and Company |
|
| D006571 |
| Heterocyclic Compounds |