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

NCT06823362 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: - PENTOX-BIO-002-2022
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy; Healthy Donors

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic Outcome Measures

  Peak Plasma Concentration (Cmax)

  0 to 24 hours

• Pharmacokinetic Outcome Measures

  Area under the plasma concentration versus time curve (AUC)

  0 to 24 hours

Study Arms (4)

1 Fasting

ACTIVE COMPARATOR

Trental® 400 mg Fasting

Drug: Pentoxifylline

2 Fasting

ACTIVE COMPARATOR

pentoxifylline TQ 400 mg Fasting

Drug: Pentoxifylline

1 Fed

ACTIVE COMPARATOR

Trental® 400 mg Fed

Drug: Pentoxifylline

2 Fed

ACTIVE COMPARATOR

pentoxifylline TQ 400 mg Fed

Drug: Pentoxifylline

Interventions

Pentoxifylline DRUG

400 mg

1 Fasting; 1 Fed

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Atencion e Investigacion Medica: lead

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Mauricio - Vargas, Ms

CONTACT

+57 3138590569; mauricio.vargas@caimed.com

Contanza N Morales, MD

CONTACT

57(601) 8707070; comite.epidemiologia@caimed.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 12, 2025
• Study Start: April 10, 2025
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 2025 - 2035
• Access Criteria: Indicate whether a proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed