Clinical Trial: The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers

Brief Summary: The objective of this study is to evaluate the systemic exposures of WH-1 ointment which includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers following topical application of WH-1.

Detailed Summary: This trial is designed as an open label, non-comparative study to evaluate the pharmacokinetic profiles of salvigenin and asiaticoside A in subjects who received the treatment of WH-1 ointment for diabetic foot ulcers. A total of 12 subjects will be completed in study. Each subject will be applied the one dose of WH-1 ointment on Day 1 following with the blood sampling collection, then twice a day of WH-1 application from Day 2 to Day 13, and another blood sampling collection scheduled on Day 14 after one dose application.
Sponsor: Oneness Biotech Co., Ltd.

Current Primary Outcome:

  • Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax) [ Time Frame: Day1 ]
    1. Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
    2. Area under the concentration-time curve from 0 to the time of last quantifiable level (AUC0-t)
    3. Maximum observed level (Cmax)
  • Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (Cmax,ss, AUC0-τ) [ Time Frame: Day14 ]
    1. Maximum observed plasma concentration at steady state (Cmax,ss)
    2. Area under the concentration versus time curve from time zero to the end of a dosing interval (AUC0-τ).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F) [ Time Frame: Day1 ]
    1. Time to peak concentration (Tmax)
    2. Mean residence time (MRT)
    3. Elimination half-life (T1/2)
    4. Apparent volume of distribution (Vd/F)
    5. Apparent clearance (CL/F)
  • Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss) [ Time Frame: Day14 ]
    Time to peak concentration at steady state (Tmax,ss)


Original Secondary Outcome: Same as current

Information By: Oneness Biotech Co., Ltd.

Dates:
Date Received: January 21, 2015
Date Started: July 2015
Date Completion: September 2018
Last Updated: January 25, 2017
Last Verified: January 2017