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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