Pharmacokinetic Profile of Rosemary Extract Supplement

Sponsor
CJ CheilJedang (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05931341
Collaborator
(none)
12
3
4

Study Details

Study Description

Brief Summary

This study is a clinical trial to observe changes in biomarkers in the blood at pre- and post-supplementation of rosemary extract in healthy adults.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Rosemary extract
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
The Effects of Oral Adminstration of Softgel Capsule Including Rosemary Extract on Pharmacokinetic Profile in Healthy Adults
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dosage 1

Dietary Supplement: Rosemary extract
Softgel capsule including rosemary extract

Experimental: Dosage 2

Dietary Supplement: Rosemary extract
Softgel capsule including rosemary extract

Experimental: Dosage 3

Dietary Supplement: Rosemary extract
Softgel capsule including rosemary extract

Outcome Measures

Primary Outcome Measures

  1. Concentration in plasma [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy subjects aged between 25 and 55 years

  • Non-smoker

  • Body Mass Index (BMI) between 20 and 30 kg/m2

Exclusion Criteria:
  • Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, endocrine, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • CJ CheilJedang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CJ CheilJedang
ClinicalTrials.gov Identifier:
NCT05931341
Other Study ID Numbers:
  • CJFNT000001
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 5, 2023