At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 18 enrolled
Drug / intervention
Naringenin +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Safety and Pharmacokinetic Evaluation of Naringenin: Single Dose Escalation Randomized Double Blind Controlled Trial
In Brief
A Early Phase 1 clinical trial evaluating Naringenin and Placebo for Safety Issues and Pharmacokinetics. Completed, enrolled 18 participants across 1 site.
Detailed Summary
This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration of the extract.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety Issues, Pharmacokinetics
CountriesUnited States
CollaboratorsLouisiana Clinical and Translational Science Center
Timeline
Early Ph 1CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
First PostedJul 2018
Primary CompletionSep 2018
TodayJul 2026
First PostedJul 11, 2018
Enrollment StartMay 25, 2018
Primary CompletionSep 28, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.0 years ago
Interventions
Naringenindietary
An extract of Citrus Sinensis containing naringenin and its precursor naringin
Placeboother
Cellulose