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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: Bosentan Dispersible Tablets; Drug: Tracleer Tablet for Oral Suspension

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • ACDIMA Biocenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The subject is male & aged between eighteen to forty-five years (18 - 45), both inclusive.
• The subject is within the limits for his height & weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
• The subject is willing to undergo the necessary pre- & post- medical examinations set by this study.
• The results of medical history, physical examination, vital signs & conducted medical laboratory tests are normal as determined by the clinical investigator.
• The subject tested negative for Hepatitis B (HBsAg), Hepatitis C (HCVAb) and human immunodeficiency virus (HIVAb).
• There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
• The subject is able to understand and willing to sign the informed consent form.
• The subject has normal cardiovascular system, pulmonary system & ECG recording.
• The subject kidney and liver functions (AST & ALT enzymes) tests are within normal range.
• The subject blood pressure is ≥ 110/70 mmHg before dosing.

Exclusion Criteria:

• The subject is a heavy smoker (more than 10 cigarettes per day).
• The subject has suffered an acute illness one week before dosing.
• The subject has a history of or concurrent abuse of alcohol.
• The subject has a history of or concurrent abuse of illicit drugs.
• The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
• The subject has been hospitalized within three months before the study or during the study.
• The subject is vegetarian.
• The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 48 hours after dosing in both study periods.
• The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study, unless otherwise judged acceptable by the clinical investigator.
• The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
• The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study.
• The subject has donated blood within 80 days before first dosing.
• The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
• The subject has consumed any drugs that may affect pharmacological or pharmacokinetic properties of Bosentan. (for example: fluconazole, amiodarone, ketoconazole, itraconazole, amprenavir, erythromycin, fluconazole, diltiazem, Cyclosporine A, Glyburide, Norethindron, Ethinyl estradiol, Simvastatin, lopinavir, ritonavir, Rifampin) two weeks before and after the study and during the study.
• The subject suffer from phenylketonuria disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bosentan 32 mg Dispersible Tablets	Drug: Bosentan Dispersible Tablets; 1 tablet of 32 mg Bosentan; Drug: Tracleer Tablet for Oral Suspension; 1 tablet of 32 mg Bosentan
Active Comparator: Tracleer® 32 mg Tablets for Oral Suspension; Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan)	Drug: Bosentan Dispersible Tablets; 1 tablet of 32 mg Bosentan; Drug: Tracleer Tablet for Oral Suspension; 1 tablet of 32 mg Bosentan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration obtained (Cmax)	two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax	23 hours
AUC from time 0 to last collection time t (AUC0-t)	two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-t	23 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC from time 0 to infinity (AUC0-inf)	Description Statistics	23 hours
Time of the maximum measured plasma concentration (Tmax)	Description Statistics	23 hours

Collaborators and Investigators

• Sponsor: Humanis Saglık Anonim Sirketi

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2024
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 27, 2024

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Endothelin Receptor Antagonists; Bosentan
• Other Study ID Numbers: 1293-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No