Clinical trial
Open-label, Randomized, Crossover, Two-period, Two-sequence Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex®, Tablets, 160 mg (BRISTOL-MYERS SQUIBB GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Condition
NCT03799536 is registered in ClinicalTrials.gov with Pharmtechnology LLC as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- Open-label, Randomized, Crossover, Two-period, Two-sequence Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex®, Tablets, 160 mg (BRISTOL-MYERS SQUIBB GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Condition
- Lead sponsor
- Pharmtechnology LLC
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- January 9, 2019
- Completion date
- February 11, 2019
- Enrollment
- 36 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
bioequivalence