A Randomized, Open-label, 2-way-crossover Study Assessing the Bioequivalence Between Single Doses of 5 mg Concor® Tablets (Manufactured by Merck/China Nantong) and 5 mg Concor® Tablets (Manufactured by Merck/Germany Darmstadt) in Chinese Healthy Participants Under Fed or Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition
研究概览
简要总结
The purpose of this study is to assess is the bioequivalence (BE) of Concor 5 milligram (mg) tablets manufactured by Merck/China Nantong (test product) and Concor 5 mg tablets manufactured by Merck/Germany Darmstadt (reference product) in Chinese healthy participants under fed or fasted 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests and cardiac monitoring
- •Participant must have a body weight within 50-90 kilogram (kg) and body mass index (BMI) within the range 19-26 kilogram per meter square (kg/m2) (inclusive)
- •Participant must have negative screen for alcohol and drugs of abuse at screening and on admission
- •Both male and female participants. The Investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable
- •Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF
- •Other protocol defined inclusion criteria could apply
排除标准
- •Participant must not have any condition, including any uncontrolled disease state, that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
- •Participant should not have positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, and treponema pallidum antibodies
- •Participant must not have received any prescription or non-prescription medication within 28 days before the first study intervention administration, including multivitamins and herbal products (example, St John's Wort, or traditional Chinese medicines)
- •Participant must not have participation in a study trial within 90 days prior to first drug administration; Blood donation (equal or more than 400 milliliter [mL]) or significant blood loss within 90 days prior to first drug administration
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
First Test Concor (Fasted), Then Reference Concor (Fasted)
Participants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by single oral dose of reference Concor tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
干预措施: First Test Concor (Fasted) (Drug)
First Reference Concor (Fasted), Then Test Concor (Fasted)
Participants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by single oral dose of Test Concor tablet on day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
干预措施: First Reference Concor (Fasted) (Drug)
First Test Concor (Fed), Then Reference Concor (Fed)
Participants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Reference Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.
干预措施: First Test Concor (Fed) (Drug)
First Reference Concor (Fed), Then Test Concor (Fed)
Participants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Test Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.
干预措施: First Reference Concor (Fed) (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition
时间窗: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
次要结局
- Number of Participants with Abnormal Vital Signs, Laboratory Variables, 12-Lead Electrocardiogram (ECG) and Physical Examination(Baseline up to Day 30 (approximately 4 weeks))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation(Baseline up to Day 30 (approximately 4 weeks))