Safety assessment and pharmacokinetics of nanoparticle WellCap Kaminn in healthy human volunteer

Phase 1

Recruiting

• Conditions: Healthy Volunteers; Curcumin; Nanocurcumin; Pharmacokinetics; Safety

• Registration Number: TCTR20191207003
• Lead Sponsor: Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-07
• Study Completion: 2020-10-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

- healthy volunteer
- Age between 18 - 45 years old
- Signed informed consent

Exclusion Criteria

- Woman who are pregnancy, breastfeeding or planning to become pregnant during the course of the trial
- There are medical history that allergic turmeric
- Eating natural product containing turmeric or curcumin, or foods that contain turmeric or curcumin within 14 days before ่joining the research project
- Patient who have a congenital disease or undergoing treatment with immunosuppressants, antibiotics, anti-inflammatory drugs, or diagnosed with chronic or immunocompromised diseases such as high blood pressure, diabetes, hepatitis, kidney disease etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of increasing doses of WellCap Kaminn in healthy subjects 48 hour adverse events, vital signs and adverse events, vital signs and laboratory assessments

Secondary Outcome Measures

Name	Time	Method
Investigation of the pharmacokinetics of WellCap Kaminn in healthly subject 48 hour Area Under the Curve, Maximum Concentration and ime until maximum concentration