Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets (NCT06484673) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets
Jordan32 participantsStarted 2024-04-21
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ha…
What they're measuring
1
Maximum concentration obtained (Cmax)
Timeframe: 23 hours
2
AUC from time 0 to last collection time t (AUC0-t)