Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCentro de Atencion e Investigacion Medica
About this trial
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.
Eligibility criteria
Qualifiers
Men or women between 18 and 50 years of age at the time of signing the informed consent form.
Female participants who are capable of conceiving must be using adequate contraceptive methods for the adequate contraceptive methods for the past 6 months and agree to continue using an adequate method of contraception for the adequate contraceptive method for 30 days after signing the consent form.
Have been clinically diagnosed as healthy by the study physician.
Subjects with clinical laboratory results within the normal range and/or fit by medical medical selection. (Table 2)
Disqualifiers
Subject diagnosed with renal, cardiac, hepatic, immunologic, dermatologic, endocrine, gastrointestinal, neurologic or psychiatric disease, endocrine, gastrointestinal, neurological or psychiatric disease.
Subject with diagnosis of hematological disorders, such as anemias and/or polycythemia.
Subjects with a history of gastric surgery.
Permanent or temporary use during the last 15 days of any type of medication. days prior to the administration of the drug, either on their own initiative or by medical prescription.
Trial design
Treatments tested in this trial
- Pentoxifylline
- Pentoxifylline
Treatment groups
40 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov