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Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets

NCT06484673 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-07-03

No results posted yet for this study

Summary

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Bosentan 32 mg Dispersible Tablets versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in healthy subjects under fasting condition.

Conditions

Interventions

DRUG

Bosentan Dispersible Tablets

1 tablet of 32 mg Bosentan

DRUG

Tracleer Tablet for Oral Suspension

1 tablet of 32 mg Bosentan

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-04-21
Primary Completion
2024-05-22
Completion
2024-05-27

Countries

  • Jordan

Study Locations

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Entities

Diseases

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 NCT06484673 on ClinicalTrials.gov