Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions (NCT06823362) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions
40 participantsStarted 2025-04-10
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Men or women between 18 and 50 years of age at the time of signing the informed consent form.
informed consent. - Women who are not able to conceive, who are not pregnant or breastfeeding. (To be considered not able to conceive she must be at least 1 year postmenopausal).
postmenopausal for at least 1 year or be surgically sterile). Table 2.
* 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)
* Subjects were non-smokers for the last 3 months at the time of screening.
* Having signed the informed consent for the study.
* Body mass index between 18-30 kg/m2.
* Subject with complete contact information (cell phone and/or landline contact, address).
* Subject who has a family member or guardian with a contact telephone number.
* Subject with the availability of time to comply with the scheduled visits and activities.
* Subject who is willing to comply with the prohibitions and restrictions specified in this protocol.
Exclusion Criteria:
* Subject diagnosed with renal, cardiac, hepatic, immunologic, dermatologic, endocrine…