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

Centro de Atencion e Investigacion Medica

Status and phase: Not yet enrolling; Phase 4

Conditions: Healthy; Healthy Donors

Treatments: Drug: Pentoxifylline

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06823362

- PENTOX-BIO-002-2022

Details and patient eligibility

About

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.

Full 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)

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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, 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.

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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups

1 Fasting

Active Comparator group

Description:

Trental® 400 mg Fasting

Treatment:

Drug: Pentoxifylline

Drug: Pentoxifylline

2 Fasting

Active Comparator group

Description:

pentoxifylline TQ 400 mg Fasting

Treatment:

Drug: Pentoxifylline

Drug: Pentoxifylline

1 Fed

Active Comparator group

Description:

Trental® 400 mg Fed

Treatment:

Drug: Pentoxifylline

Drug: Pentoxifylline

2 Fed

Active Comparator group

Description:

pentoxifylline TQ 400 mg Fed

Treatment:

Drug: Pentoxifylline

Drug: Pentoxifylline