Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects

NCT04101370 | Completed Phase 1 DMC

• 1 other identifier: BOZ-501
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer® Actelion)

Conditions

Bioequivalence

Keywords

AUC; Cmax; Pharmacokinetics; bosentan; fasting

Outcome Measures

Primary Outcomes (2)

• Cmax

  Pharmacokinetics of bosentan by Assessment of Observed Maximum Plasma Concentration (Cmax)

  0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.

• AUC(0-t)

  Pharmacokinetics of bosentan by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))

  0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.

Study Arms (2)

Bosentan

EXPERIMENTAL

Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition

Drug: Bosentan 125 mg

Tracleer®

ACTIVE COMPARATOR

Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition

Drug: Tracleer 125Mg Tablet

Interventions

Bosentan 125 mg DRUG

Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition

Also known as: bosentan

Bosentan

Tracleer 125Mg Tablet DRUG

Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition

Also known as: bosentan

Tracleer®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent form.
• Healthy male aged 18 to 45 years.
• Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
• Have a body mass index between 18,5 and 30 kg/m2.
• Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.
• Ability to keep fasting state for at least 14 hours.
• Consent and ability to respect the schedule of visits and the points of the Protocol.

You may not qualify if:

• History of serious allergic problems/events.
• Medicinal intolerance.
• Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
• Psychiatric disorders, history of epilepsy and seizures.
• Acute infectious diseases in less than 4 weeks before the start of the study.
• Subjects who have taken medication 2 weeks preceding before the study.
• Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
• Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
• History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
• Smokers.
• Participation in other clinical training is less than than for 3 months before the study.
• Lack of signed informed consent form.
• % deviation from references in lab tests.
• Positive testing for alcohol, drugs.
• Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.

Sponsors & Collaborators

• Geropharm: lead

Study Sites (1)

Clinical Hospital № 3

Yaroslavl, 150007, Russia

Location

MeSH Terms

Conditions

Fasting

Interventions

Bosentan; Tablets

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover Assignment two-way crossover

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 24, 2019
• Study Start: May 24, 2018
• Primary Completion: June 20, 2018
• Study Completion: June 20, 2018
• Last Updated: September 24, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)