Lime Powder Regimen in Healthy Volunteers

Phase 1

• Conditions: Kidney Stone; Oxidative Stress

• Registration Number: NCT01273025
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-07
• Last Update Submitted: 2011-01-07
• Study First Posted: 2011-01-10
• Last Update Posted: 2011-01-10
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The pharmacokinetic parameters of plasma and urine citrate	6 months	The pharmacokinetic parameters of plasma and urine citrate incluiding Cmax, Tmax, Half life, AUC, and elimination rate constant

Trial Locations

Locations (1)

Chula clinical research center; 🇹🇭 Bangkok, Thailand