Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)

Texas Tech University Health Sciences Center

Status and phase

Completed

Early Phase 1

Conditions

Healthy

Treatments

Dietary Supplement: 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0

Study type

Interventional

Funder types

Other

Identifiers

NCT02114957

A12-3742

Details and patient eligibility

About

This study is to investigate how human bodies absorb and metabolize two herbal drugs. The information is critical for drug development and could not be obtained from any other studies using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies indicated that AGN and decursin/DA were quite safe to animals and human.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Health subjects weighing between 50 to 91 kilograms (110 to 200 pounds)
Subjects 18 to 65 years of age
Subjects having normal hepatic, renal and bone marrow function as assessed by history, physical and clinical chemistry analysis

Exclusion criteria

Subjects positive for HIV, HBV and HCV
Subjects with diabetes-due to length of fasting
Subjects regularly taking any kind of prescription medications
Subjects taking oral contraception, hormone-containing IUDs, contraception implants, or Depo medroxyprogesterone injections
Subjects taking any food or herbal supplements containing AGN (e.g. CognIQTM, D-Cursinol, Decursinol-50™, Ache Action™, Fast-Acting Joint Formula, EstroG-100™) within 30 days of the study.
Female subjects that are pregnant, <6 months postpartum, or breastfeeding women.