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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.