HealthyPhase 4PentoxifyllineNCT06823362
Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions
A Phase 4 study testing Pentoxifylline in people with Healthy and Healthy Donors, run by Centro de Atencion e Investigacion Medica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Donors
- What is being tested?
- Pentoxifylline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 30 Sep 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
- medical prescription. Except female patients who are planning regularly with the same contraceptive method.
- the same contraceptive method in the last 6 months prior to the start of the present study.
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- the present study.
- Smoker in the last 3 months, regardless of the number of cigarettes at the time of selection.
- selection.
- Consumption of xanthines from coffee, tea or chocolate during the previous 48 hours.
- Drinking alcohol in excess of 16 g 15 days prior to administration of the investigational drug.
- equivalent to 1 beer or 2 glasses of wine.
- Positive test for the consumption of drugs of abuse or psychoactive substances at the time of screening or prior to administration of the (Table 2).
- Known hypersensitivity to the active substance or excipients of the test product.
- Medical history of angioedema or anaphylaxis.
- Pregnant or lactating woman.
- Subject diagnosed with human immunodeficiency virus, hepatitis B or hepatitis C positive.
- hepatitis C positive.
- Having participated in clinical studies in the 4 months prior to the start of the present study.
- Having donated blood or reported blood loss of more than 500 mL in the 30 days prior to subject selection.
- prior to subject selection.
- Subject has a clinically significant acute illness or temperature > 38°C within 24 hours prior to the within 24 hours prior to investigational product administration.
- Subject has a contraindication to blood collection due to bleeding or thrombotic disorders.
- bleeding disorders or thrombocytopenia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bioequivalence Study of Pentoxifylline 400 Mg in Sustained Release Tablets in Sustained Release Tablets in Healthy Subjects Under Fasting and Fed Conditions
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.
Read the 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
- Being tested
- Pentoxifylline
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
400 mg
PentoxifyllineDrug
400 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 Fasting | Active comparator | Trental® 400 mg Fasting Receives: Drug: Pentoxifylline |
| 2 Fasting | Active comparator | pentoxifylline TQ 400 mg Fasting Receives: Drug: Pentoxifylline |
| 1 Fed | Active comparator | Trental® 400 mg Fed Receives: Drug: Pentoxifylline |
| 2 Fed | Active comparator | pentoxifylline TQ 400 mg Fed Receives: Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Outcome Measures
Peak Plasma Concentration (Cmax)
Measured: 0 to 24 hours
Pharmacokinetic Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Measured: 0 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start10 Apr 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atencion e Investigacion Medica
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Humberto Reynales MD MSc PhD, Centro de Atencion e Investigacion Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823362
- Sponsor's protocol ID
- - PENTOX-BIO-002-2022
- Acronym
- Pentoxifylline
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Pentoxifylline 400 Mg in Sustained Release Tablets in Sustained Release Tablets in Healthy Subjects Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT06823362
- Acronym / sponsor ID
- Pentoxifylline / - PENTOX-BIO-002-2022
- Conditions
- Healthy, Healthy Donors
- Keywords
- Bioequivalence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centro de Atencion e Investigacion MedicaResearch network
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 Fasting | Active comparator | Drug: PentoxifyllineTrental® 400 mg Fasting |
| 2 Fasting | Active comparator | Drug: Pentoxifyllinepentoxifylline TQ 400 mg Fasting |
| 1 Fed | Active comparator | Drug: PentoxifyllineTrental® 400 mg Fed |
| 2 Fed | Active comparator | Drug: Pentoxifyllinepentoxifylline TQ 400 mg Fed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
- medical prescription. Except female patients who are planning regularly with the same contraceptive method.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentoxifylline400 mg | Drug | 1 Fasting, 1 Fed |
| Pentoxifylline400 mg | Drug | 2 Fasting, 2 Fed |
Primary outcome
Pharmacokinetic Outcome Measures
Time frame: 0 to 24 hours
Peak Plasma Concentration (Cmax)
Pharmacokinetic Outcome Measures
Time frame: 0 to 24 hours
Area under the plasma concentration versus time curve (AUC)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pentoxifylline in people with Healthy and Healthy Donors, run by Centro de Atencion e Investigacion Medica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mauricio - Vargas, Ms (+57 3138590569, mauricio.vargas@caimed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Outcome Measures (time frame: 0 to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.