Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sotalol · 1 trial · 1 indication
Maximum concentration in plasma among observed concentrations at pre-specified time points
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
| Arm | Type | Description |
|---|---|---|
| Sequence AB | EXPERIMENTAL | Subjects assigned to sequence AB will receive a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 1 and a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence BA | ACTIVE_COMPARATOR | Subjects assigned to sequence BA will receive a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 1 and a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Name | Type | Description |
|---|---|---|
| Sotalol | DRUG | Sotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus |
| Sotalex | DRUG | Sotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH \& Co. KGaA, Germany |
Inclusion Criteria: * Caucasian men or women aged between 18 to 55 years * Body mass index 18.5-30 kg/m² * Subjects who have no signs of disease during the screening, and whose screening is conducted within 21 days after the registration in the trial * Subjects whose laboratory blood and urine valu...
Sotalol is a small molecule drug being studied for bioequivalence, meaning it is being tested to confirm that a generic version matches the reference product in how it is absorbed and behaves in the body. The specific study involves healthy volunteers under fasting conditions.
Sotalol is being developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The company is conducting a Phase 1 bioequivalence study of the drug.
Sotalol is in Phase 1 clinical development. The drug is investigational and not yet approved for marketing. It is being studied in a single Phase 1 bioequivalence trial that has been completed.
Sotalol has one completed clinical trial, NCT03799536, a Phase 1 bioequivalence study comparing Sotalol tablets 160 mg from Pharmtechnology LLC to Sotalex tablets 160 mg from Bristol-Myers Squibb in healthy volunteers under fasting conditions. The trial enrolled 36 participants in Belarus.
Sotalol is being studied as a generic equivalent to Sotalex, a reference product. The bioequivalence trial compares Sotalol tablets from Pharmtechnology LLC to Sotalex tablets from Bristol-Myers Squibb to determine if they are therapeutically equivalent.