LimePKphase1: Lime Powder Regimen in Healthy Volunteers

Sponsor

Chulalongkorn University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01273025

Collaborator

(none)

Enrollment

Location

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone Oxidative Stress	Dietary Supplement: Lime powder regime	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Dec 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2011

Anticipated Study Completion Date :

Mar 1, 2011

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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