NCT06484673已完成1 期
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
Humanis Saglık Anonim Sirketi1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年4月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum concentration obtained (Cmax)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bosentan 32 mg Dispersible Tablets
Experimental
Bosentan 32 mg Dispersible Tablets
干预措施: Bosentan Dispersible Tablets (Drug)
Bosentan 32 mg Dispersible Tablets
Experimental
Bosentan 32 mg Dispersible Tablets
干预措施: Tracleer Tablet for Oral Suspension (Drug)
Tracleer® 32 mg Tablets for Oral Suspension
Active Comparator
Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan)
干预措施: Bosentan Dispersible Tablets (Drug)
Tracleer® 32 mg Tablets for Oral Suspension
Active Comparator
Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan)
干预措施: Tracleer Tablet for Oral Suspension (Drug)
结局指标
主要结局
Maximum concentration obtained (Cmax)
时间窗: 23 hours
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
AUC from time 0 to last collection time t (AUC0-t)
时间窗: 23 hours
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
次要结局
- AUC from time 0 to infinity (AUC0-inf)(23 hours)
- Time of the maximum measured plasma concentration (Tmax)(23 hours)
研究者
研究点 (1)
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