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Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions

NCT06823362 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Healthy
  • Healthy Donors

Interventions

DRUG

Pentoxifylline

400 mg

DRUG

Pentoxifylline

400 mg

Sponsors & Collaborators

  • Centro de Atencion e Investigacion Medica

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2025-06-30
Completion
2025-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06823362 on ClinicalTrials.gov