NCT06823362 · ClinicalTrials.gov record · last posted 2025-02-17
Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions
Study acronym: Pentoxifylline
StatusNot Yet Recruiting
PhasePhase 4
Started2025-04-10
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Record status
This record was last updated February 17, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
Two bioequivalence studies of Pentoxifylline will be carried out in 40 healthy subjects, the first in a fasting condition 40 healthy subjects, the first in fasting condition and the second in postprandial condition.
postprandial condition, the two studies follow the same design: Complete crossover design, randomized, comparative of two study formulations, in single dose of 400 mg of Pentoxifylline sustained release tablets, 2 periods, with a washout time of 7 days between doses, the 7 days between doses, participation as a subject in these studies involves a risk studies involves a higher than minimal risk for subjects.
Amendment record
1 amendment on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended once since 2025-02-10. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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| NCT Number |
NCT06823362 |
| Lead Sponsor |
Centro de Atencion e Investigacion Medica
|
| Conditions |
Healthy, Healthy Donors |
| Enrollment |
40 participants |
| Start Date |
2025-04-10 |
| Primary Completion |
2025-06-30 (estimated) |
| Study Completion |
2025-09-30 (estimated) |
| Updated on ClinicalTrials.gov |
2025-02-17 |