Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)

April 14, 2014 updated by: Texas Tech University Health Sciences Center

Single Oral Dose Pharmacokinetics of Decursin/Decursinol Angelate in Healthy Adult Men and Women

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Amarillo, Texas, United States, 79106
        • Clinical Research Unit, School of Medicine, Texas Tech University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: study herb
Dietary supplement: 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0, 0.5, 1, 2, 3, 4, 6, 8, 12 , 24, 48 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb
Time Frame: 0 and 24 hours post-dose
0 and 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center

Investigators

  • Principal Investigator: Jinhui Zhang, Ph.D, Texas Tech University Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (ESTIMATE)

April 15, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A12-3742

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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