drugset / Trial / NCT03948243

Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

NCT03948243

NaSingle-groupOpen-labelOther

Summary

Human safety studies will be carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a red clover dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) will be given with four selected FDA-approved drugs to determine if the Licorice supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies predict that the licorice supplement might affect the metabolism or break down of these probe drugs.

Timeline

Start
2019-04-01
Primary completion
2020-07-31
Completion
2022-04-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Alprazolam Small molecule 2 mg
Subject Caffeine Small molecule 100 mg
Subject Dextromethorphan Unknown 30 mg
Subject Licorice Traditional medicine (herbal / TCM) 75 mg
Subject Tolbutamide Small molecule 250 mg

Indications

No indication recorded.