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Inderal LA · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Propranolol Hydrochloride Extended-Release Capsules 160 mg |
| 2 | ACTIVE_COMPARATOR | Inderal® LA Capsules 160 mg |
| Name | Type | Description |
|---|---|---|
| Propranolol Hydrochloride Extended-Release Capsules 160 mg | DRUG | 160mg, single dose fed |
| Inderal® LA Capsules 160 mg | DRUG | 160mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administ...
Inderal LA is a long-acting formulation of propranolol hydrochloride, a beta-blocker. In the clinical trials listed, it was studied in healthy volunteers to assess the effects of food and fasting conditions on the drug's absorption. The trials compared Inderal LA 160 mg capsules with a generic propranolol hydrochloride extended-release 160 mg capsule.
Inderal LA is developed by Viatris Inc., a global healthcare company. Viatris is publicly traded on the NASDAQ under the ticker symbol VTRS. The company conducted clinical studies to evaluate the bioequivalence of Inderal LA compared with a generic version of the drug.
Inderal LA is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving healthy adult volunteers. These early-stage trials focused on pharmacokinetic comparisons under fed and fasting conditions, and no Phase 2 or Phase 3 trials are listed for this drug.
Inderal LA has been studied in two completed Phase 1 clinical trials. NCT00647608 was a food study comparing Inderal LA 160 mg capsules with propranolol hydrochloride extended-release 160 mg capsules in 98 healthy participants. NCT00647816 was a fasting study with the same comparison in 100 healthy participants. Both trials were conducted in the United States.
Inderal LA is a brand-name formulation of propranolol hydrochloride extended-release capsules. In clinical trials, it was compared directly with a generic propranolol hydrochloride extended-release 160 mg capsule to assess bioequivalence. Both products contain the same active ingredient, propranolol, but may differ in inactive ingredients or release characteristics.