A phase I, open-label, single-dose, randomized, cross-over, 3 parts study to evaluate in healthy subjects the relative bioavailability of eltrombopag new capsule formulation (CPS) in comparison to the reference marketed film-coated tablets (FCT) (Part 1), the pharmacokinetic comparability of eltrombopag CPS and marketed FCT (Part 2) and the effect of food on the pharmacokinetics of eltrombopag administered as CPS (Part 3) - Bioavailability eltrombopag CPS vs FCT

ovartis0 个研究点目标入组 248 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- Male and female subjects who are 18 to 55 years of age on the day of Informed
•Consent signature
•- Subjects in good health condition as determined by no clinically significant
•findings from medical history, physical examination, vital signs, and ECG, as
•well as laboratory values within the reference range at the local laboratory,
•unless deemed not clinically significant by the Investigator or designee
•- Body mass index (BMI) of 18.0 to 29.9 kg/m2, with body weight greater than or
•equal to 50 kg for males and 45 kg for females and no more than 120 kg

•- A history or presence of clinically significant ECG abnormalities or a family
•history or presence of prolonged QT-interval syndrome
•- Presence of hepatitis B or C virus, or human immunodeficiency virus
•- Clinical evidence of renal disease or liver disease or liver injury
•- Any surgical or medical condition which might significantly alter the
•absorption, distribution, metabolism or excretion of drugs, such as
•gastrectomy, gastroenterosomy, bowel restriction or colecystectomy
•- Administration of CYP3A4/5 inhibitors or inducers within 4 weeks prior to
•screening and until 2 weeks after EOT, for their potential interaction with
•hormonal contraceptive methods
•- Consumption of any antacids, e.g., liquid antacids (e.g., Maalox, Mylanta,
•Amphogel, Milk of Magnesia), chewable antacids (e.g., TUMS*) during 14 days
•prior the first dose of study medication and until end-of-treatment
•-Not willing to avoid the following fruits and their juices: grapefruit,
•grapefruit hybrids, Seville oranges, pomelos, pomegranates, cranberries and
•star fruits from 14 days prior to the first dosing and until the
•end-of-treatment
•- Use of any prescription or non-prescription medication (OTC) (including
•aspirin and non-steroidal anti-inflammatory drugs [NSAIDs]), herbal medication,
•dietary supplements or vitamins during 14 days prior to first dosing and until
•end-of-treatment

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