NCT06823362

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Centro de Atencion e Investigacion Medica · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

To establish the main pharmacokinetic variables of the two formulations for the active formulations for the active ingredient pentoxifylline and the metabolites metabolites M1 Metabolite I (1- \[5-hydroxyhexyl\] -3,7- \[5-hydroxyhexyl\] -3,7- dimethylxanthine) and dimethylxanthine) and M5 Metabolite V (1- \[3- \[3-carboxypropyl\] -3,7- \[3-carboxypropyl\] -3,7- dimethylxanthine)

Conditions

• Healthy
• Healthy Donors

Interventions

Type	Name	Description
DRUG	Pentoxifylline	400 mg
DRUG	Pentoxifylline	400 mg

Timeline

• Start date: 2025-04-10
• Primary completion: 2025-06-30
• Completion: 2025-09-30
• First posted: 2025-02-12
• Last updated: 2025-02-17