jRCT2071250139进行中（未招募）不适用
An Open-label, Fixed-sequence, Two-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Mitiglinide and Pioglitazone in Healthy Participants
未提供0 个研究点目标入组 32 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
入排标准
- 年龄范围
- 18age old over 至 55age old under（—）
- 性别
- All
入选标准
- •Participants with suitable veins for cannulation or repeated venipuncture.
- •All females must have a negative serum pregnancy test at the Screening Visit and on admission to the study site.
- •Females of childbearing potential must agree to use a highly effective contraception method from enrollment.
- •Male Participants, if heterosexually active, must practice true abstinence or use condoms during the trial and their female partners of childbearing potential must use additional effective contraception during the trial.
- •Body Mass Index (BMI) between 18 and 35 kg/m^2 and weigh at least 50 kg.
排除标准
- •History of any clinically important disease or disorder which may put the participant at risk or influence the results, including:
- •a. Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal (GI) tract
- •b. Cardiovascular disease
- •c. Neuromuscular or neurogenic disease
- •d. Type 1 or type 2 diabetes mellitus
- •History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
- •History of clinically significant cardiovascular, dermatological, respiratory, neurological, psychiatric or GI disease disorder.
- •History of malignant neoplastic disease.
- •History or presence of GI disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •Any clinically important illness, medical/surgical procedure, or trauma.
- •Any clinically important abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results.
- •Basal calcitonin level >= 35 ng/L or history/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2).
- •Uncontrolled thyroid disease.
- •Any positive result on screening for serum human immunodeficiency virus (HIV).
- •Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to AZD5004, or to mitiglinide and/or pioglitazone.
- •Participants who have previously received AZD5004.
研究者
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