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NCT03937908 · ClinicalTrials.gov registry record · Early Phase 1
Pharmacokinetics Centella Asiatica Product (CAP) in Mild Cognitive Impairment
A Early Phase 1 study, sponsored by Oregon Health and Science University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT03937908 is a Early Phase 1 study that was terminated before completion, run by Oregon Health and Science University. The registered enrollment target is 5 participants.
The verdict
NCT03937908, a Early Phase 1 study, was terminated before completion, sponsored by Oregon Health and Science University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract product (CAP) in mildly demented elders on cholinesterase inhibitor therapy. Compound levels will be measured in human plasma and urine over 10 hours after acute oral administration of two doses of the botanical extract product. The dose giving maximum plasma levels (Cmax)closest to those observed in the investigator's mouse studies, the area under the curve (AUC0-12), as well as the rate of clearance (t ½) of the known compounds and time of maximum concentration (tmax), will be identified. These data will be used to inform decisions on the dosage and dosing frequency for future clinical trials.
Interventions
- DRUG 2g Centella asiatica water extract product
- DRUG 4g Centella asiatica water extract product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-10-31 |
| Est. Completion | 2020-12-21 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03937908
The ClinicalTrials.gov registry entry for NCT03937908 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 2g Centella asiatica water extract product is the first listed.
NCT03937908 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03937908 about?
NCT03937908 is a clinical study titled "Pharmacokinetics Centella Asiatica Product (CAP) in Mild Cognitive Impairment". This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract product (CAP) in mildly demented elders on cholinesterase inhibitor therapy. Compound levels will be measured in human plasma and urine over 10 hours...
What is the current status of trial NCT03937908?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2019-10-31. Estimated completion is 2020-12-21.
What interventions are being tested in trial NCT03937908?
The interventions under investigation include: 2g Centella asiatica water extract product (DRUG), 4g Centella asiatica water extract product (DRUG).
Who is sponsoring clinical trial NCT03937908?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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