Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)

Early Phase 1CompletedNCT02114957

Texas Tech University Health Sciences Center20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0DIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Research Unit, School of Medicine, Texas Tech University Health Sciences Center

Amarillo, Texas, United States

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol

Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 , 24, 48 hours post-dose

Secondary Outcomes

vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb

Time frame: 0 and 24 hours post-dose

Data from ClinicalTrials.gov

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