Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults

Phase 2

Recruiting

• Conditions: healthy adults

• Registration Number: JPRN-UMIN000024567
• Lead Sponsor: Kagoshima University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Subjects who have participated in interventional studies within 16 weeks prior to signing the patient informed consent (2) Subjects who have history disease such as endocrine/metabolic disease, autoimmune disorder and immunodeficiency affects the secondary end point (3) Subjects with serious complications such as heart failure, lung diseases, kidney failure, liver failure and uncontrolled diabetes (4) Subjects with cancer or history of cancer (5) Subjects or breast-feeding women, women suspected of being pregnant and patients who do not consent to prevent conception by taking appropriate means with the assistance of their partners during the study period (6) Subjects considered unsuitable for participation in the study by the principal investigators or sub-investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Efficacy: Change in walking speed as measured by 10 meter walk test from Day 0 to Day 7 (time and number of steps)

Secondary Outcome Measures

Name	Time	Method
-Safety: Adverse event (frequency and severity) Effect on Endocrine (To reveal the endocrine on behalf of growth hormone on Day 0,7,14,28) Effect on metabolism (To reveal the metabolism on behalf of lactic acid, pyruvic acid and blood gas analysis on Day 0,7,14,28) Effect on immunity (To reveal the immunity on behalf of cytokine and chemokine on Day 0,7,14,28)