Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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study herb

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Interventions

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes