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

NCT04101370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-09-24

No results posted yet for this study

Summary

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

Conditions

  • Bioequivalence

Interventions

DRUG

Bosentan 125 mg

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

DRUG

Tracleer 125Mg Tablet

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

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-24
Primary Completion
2018-06-20
Completion
2018-06-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04101370 on ClinicalTrials.gov