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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014