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Pharmacokinetic Study of Marine Active in Health Men

Primary Purpose

Hyperuricemia, Anserine, Pharmacokinetic

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Marine active
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia, Anserine, Pharmacokinetic focused on measuring Hyperuricemia, Anserine, Pharmacokinetic

Eligibility Criteria

20 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: -Male volunteers, age between 20 to 35 years Exclusion Criteria: Chronic medical history Significant liver or renal dysfunction, Have been administrated by any drug within 2 weeks before the initiation of study.

Sites / Locations

  • China Medical University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
November 16, 2005
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00207974
Brief Title
Pharmacokinetic Study of Marine Active in Health Men
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
China Medical University Hospital

4. Oversight

5. Study Description

Brief Summary
Hyperuricemia is often associated with metabolic syndrome, which is a known precursor of atherosclerosis. The Yaizu Suisankagaku Industry Company have developed industrial production, named Marine Active. Human clinical trials showed reduction of creatine phosphokinase activity and sero-uric acid. Randomize, double blind clinical trial is entrust to our hospital. This study design is blood sampling from the health men who take 1 gm of marine active to analyse the pharmacokinetics of anserine.
Detailed Description
Hyperuricemia is a common metabolic disorder. It can result from a decreased renal uric acid excretion, increased urate production, or both. The classical association with clinical gout is well-known. The principal indications for uric acid-lowering therapy, including allopurinol, probenecid and sulfinpyrazone, are the patients with gout history, macroscopic subcutaneous tophi, frequent attacks of gouty arthritis, or a documented state of uric acid overproduction. Hyperuricemia is often associated with metabolic syndrome,which is known a percursor of atherosclerosis. For the gout attack only 5% per year of the hyperuricemic population, medical management is not indicated for patients without gouty arthritis. Diet control is the leading way to control serum uric acid level, but usually it is not enough. So how to management hyperuricemia is important and is a potential management.Histidine-containing dipeptides such as Anserine and Carnosine have been studied extensively in recent years. These dipeptides were shown to be effective in acting as buffering agents against protons developed during anaerobic exercise. Anserine and Carnosine also have strong anti-oxidant activity, anti-cancer activity, immuno-response modulation, fat reduction and enhanced wound healing functions. The Yaizu Suisankagaku Industry Company have developed industrial production process to extract and purify the dipeptides from Bonito and Tuna. The extract, named Marine Active, was able to offer anti-fatigue activity by animal trial data. Human clinical trials showed reduction of creatine phosphokinase activity and sero-uric acid. Randomize, double blind clinical trial is entrust to our hospital. This study design is blood sampling from the health men who take 1 gm of marine active to analyse the pharmacokinetics of anserine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Anserine, Pharmacokinetic
Keywords
Hyperuricemia, Anserine, Pharmacokinetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Marine active

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -Male volunteers, age between 20 to 35 years Exclusion Criteria: Chronic medical history Significant liver or renal dysfunction, Have been administrated by any drug within 2 weeks before the initiation of study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuo-Chin Huang, MD
Organizational Affiliation
Chinese-Western Medicine Cooperation, China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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Pharmacokinetic Study of Marine Active in Health Men

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