Lime Powder Regimen in Healthy Volunteers (LimePKphase1)

January 7, 2011 updated by: Chulalongkorn University

Medicinal Effect of Lime Powder Regimen in HK-2 Cell Exposed to Lithogenic Crystals and Its Citraturic and Antioxidative Responses in Healthy Volunteers

The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in Thai healthy men.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • 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

  • Thailand
      • Bangkok, Thailand, 10330
        • Chula clinical research 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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Thai healthy male or female aged 18-45 years old
  • BMI 18-25 kg/m2
  • Normal medical history, physical examination and vital signs
  • Normal screening laboratories
  • no history of drug allergies
  • Willingness to take part in the study and provide informed consent

Exclusion Criteria:

  • History of GI, liver, kidney, allergic disease or any other disease that may interfere with the bioavailability of lime powder regimen
  • History of alcohol or drug abuse
  • Heavy smoking
  • Receive any medication within 14 days prior to the study day

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pharmacokinetic parameters of plasma and urine citrate
Time Frame: 6 months
The pharmacokinetic parameters of plasma and urine citrate incluiding Cmax, Tmax, Half life, AUC, and elimination rate constant
6 months

Collaborators and Investigators

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

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Poonsin Poungpairoj, BSc, Chulalongkorn University

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

December 1, 2010

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

January 10, 2011

Last Update Submitted That Met QC Criteria

January 7, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPK-10-003

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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