Lime Powder Regimen in Healthy Volunteers (LimePKphase1)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01273025
First received: January 5, 2011
Last updated: January 7, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Kidney Stone
Oxidative Stress
Dietary Supplement: Lime powder regime
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • The pharmacokinetic parameters of plasma and urine citrate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The pharmacokinetic parameters of plasma and urine citrate incluiding Cmax, Tmax, Half life, AUC, and elimination rate constant


Enrollment: 15
Study Start Date: December 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Lime powder regime
    1 sachet of lime powder regimen with 200 ml of water
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273025

Locations
Thailand
Chula clinical research center
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Poonsin Poungpairoj, BSc Chulalongkorn University
  More Information

No publications provided

Responsible Party: Napatr Aungkasuvapala, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01273025     History of Changes
Other Study ID Numbers: PPK-10-003
Study First Received: January 5, 2011
Last Updated: January 7, 2011
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Chulalongkorn University:
pharmacokinetic
lime powder regimen
kidney stone
Oxidative stress

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014