NCT03799536View on ClinicalTrials.gov

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 Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 9, 2019

Primary Completion Date

February 4, 2019

Study Completion Date

February 11, 2019

Conditions
Bioequivalence
Interventions
DRUG

Sotalol

Sotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus

DRUG

Sotalex

Sotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH \& Co. KGaA, Germany

Trial Locations (1)

223040

National Anti-Doping Laboratory, Settl.Lesnoy

All Listed Sponsors
collaborator

National Anti-Doping Labaratory

UNKNOWN

lead

Pharmtechnology LLC

INDUSTRY

NCT03799536 - 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 Conditions | Biotech Hunter | Biotech Hunter