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Lime Powder Regimen in Healthy Volunteers (LimePKphase1)

Primary Purpose

Kidney Stone, Oxidative Stress

Status
Unknown status
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Lime powder regime
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Stone focused on measuring pharmacokinetic, lime powder regimen, kidney stone, Oxidative stress

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chula clinical research center

Outcomes

Primary Outcome Measures

The pharmacokinetic parameters of plasma and urine citrate
The pharmacokinetic parameters of plasma and urine citrate incluiding Cmax, Tmax, Half life, AUC, and elimination rate constant

Secondary Outcome Measures

Full Information

First Posted
January 5, 2011
Last Updated
January 7, 2011
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01273025
Brief Title
Lime Powder Regimen in Healthy Volunteers
Acronym
LimePKphase1
Official Title
Medicinal Effect of Lime Powder Regimen in HK-2 Cell Exposed to Lithogenic Crystals and Its Citraturic and Antioxidative Responses in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Oxidative Stress
Keywords
pharmacokinetic, lime powder regimen, kidney stone, Oxidative stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Lime powder regime
Intervention Description
1 sachet of lime powder regimen with 200 ml of water
Primary Outcome Measure Information:
Title
The pharmacokinetic parameters of plasma and urine citrate
Description
The pharmacokinetic parameters of plasma and urine citrate incluiding Cmax, Tmax, Half life, AUC, and elimination rate constant
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Poonsin Poungpairoj, BSc
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chula clinical research center
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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Lime Powder Regimen in Healthy Volunteers

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