PharmacokineticsNCT05931341
Pharmacokinetic Profile of Rosemary Extract Supplement
A study testing Rosemary extract in people with Pharmacokinetics, run by CJ CheilJedang.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Rosemary extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged between 25 and 55 years
- Non-smoker
- Body Mass Index (BMI) between 20 and 30 kg/m2
Who cannot join
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, endocrine, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease
About this study
Official title: The Effects of Oral Adminstration of Softgel Capsule Including Rosemary Extract on Pharmacokinetic Profile in Healthy Adults
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.
- Conditions
- Pharmacokinetics
- Being tested
- Rosemary extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosemary extractDietary supplement
Softgel capsule including rosemary extract
| Study group | Role | What they receive |
|---|---|---|
| Dosage 1 | Experimental | Not described Receives: Dietary Supplement: Rosemary extract |
| Dosage 2 | Experimental | Not described Receives: Dietary Supplement: Rosemary extract |
| Dosage 3 | Experimental | Not described Receives: Dietary Supplement: Rosemary extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration in plasma
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CJ CheilJedang
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931341
- Sponsor's protocol ID
- CJFNT000001
- Status last verified
- Nov 2023
- First submitted
- 26 Jun 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Adminstration of Softgel Capsule Including Rosemary Extract on Pharmacokinetic Profile in Healthy Adults
- ClinicalTrials.gov ID
- NCT05931341
- Acronym / sponsor ID
- CJFNT000001
- Conditions
- Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- CJ CheilJedangIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dosage 1 | Experimental | Dietary Supplement: Rosemary extract |
| Dosage 2 | Experimental | Dietary Supplement: Rosemary extract |
| Dosage 3 | Experimental | Dietary Supplement: Rosemary extract |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects aged between 25 and 55 years
- Non-smoker
- Body Mass Index (BMI) between 20 and 30 kg/m2
Key exclusion criteria (1 listed)
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, endocrine, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosemary extractSoftgel capsule including rosemary extract | Dietary supplement | Dosage 1, Dosage 2, Dosage 3 |
Primary outcome
Concentration in plasma
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rosemary extract in people with Pharmacokinetics, run by CJ CheilJedang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration in plasma (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.