A randomized, open label, three way crossover relative bioavailability study in healthy adult male and female subjects to evaluate the bioavailability of GRC 4039 (1 mg and 5 mg) following single oral administration of a tablet formulation under fasting and fed conditions compared with that of a capsule in fasting condition.

Glenmark Pharmaceuticals SA, Chemin de la Combeta 5, 2300 La Chaux-de-Fonds, Switzerland0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Healthy males and females within the age range of 18 to 55 years
•-Willingness to provide written informed consent to participate in the study
•-Body-mass index of > 18.5 kg/m2 and < 24.9 kg/m2
•-Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening

•-Women of child bearing potential not willing to practice adequate contraception
•-pregnant and lactating females
•-Subjects with a relevant food or drug hypersensitivity or allergy
•-Past history of anaphylaxis or angioedema
•-Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
•-Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test, renal (kidney) function test, etc.
•-Subjects with a presence or a history of clinically relevant conditions in the gastrointestinal, hepatic, renal, urogenital, cardiovascular, metabolic, endocrine or central and peripheral nervous systems
•-History of seizure or psychiatric disorders
•-Use of any recreational drug or a history of drug addiction
•-Participation in any clinical trial within the past 3 months
•-Donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication
•-Abnormal ECG

发起方

Glenmark Pharmaceuticals SA, Chemin de la Combeta 5, 2300 La Chaux-de-Fonds, Switzerland