Safety, Tolerability and Pharmacokinetics of Benfo-Oxythiamine (B-OT) in Healthy Volunteers

Summary

The goal of this clinical trial was to learn about the safety and tolerability of an investigational drug called Benfo-oxythiamine (B-OT) in healthy male volunteers. Researchers are studying B-OT to see if it might be used to treat infectious diseases and cancer. This study also looked at how the drug enters, moves through, and leaves the body. The main questions it aimed to answer were: * Is B-OT safe for humans to take? * What medical problems do participants have when taking B-OT? * How much of the drug gets into the blood? Participants: * Took B-OT capsules by mouth either once (single dose group) or once a day for 7 days (multiple dose group). * Stayed in the clinic for several days (4 to 8 nights) for close monitoring. * Gave blood and urine samples for laboratory tests; * Had physical exams, heart rhythm checks (ECG), and vital sign checks (blood pressure, heart rate, breathing rate, and temperature).

Timeline

Start

2022-03-01

Primary completion

2022-11-21

Completion

2022-11-21

Publications

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Drugs

Indications

No indication recorded.