A Randomized, Open-label, Single-dose, 2-way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Telmisartan and Rosuvastatin and YH16410 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments
研究概览
简要总结
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time.
The two treatment periods will be separated by a washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female aged 20 to 50 with a body mass index(BMI) between 18.5 and 25 kg/m2
- •Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- •Provision of signed written informed consent 20~50 yrs old, healthy Korean Subjects
排除标准
- •History of and clinically significant disease
- •Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 65 (mmHg) amd 100 ≥ Heart rate ≤ 40
- •A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- •Administration of other investigational products within 90 days prior to the first dosing.
- •Administration of herbal medicine within 28 days or administration of ethical drugs within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- •Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening
- •Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
研究组 & 干预措施
FDC YH16410
Drug: Test treatment: FDC YH16410 (Telmisartan 80mg/ Rosuvastatin 20mg).
Subjects will receive single oral dose of 1 tablet of FDC containing Telmisartan 80mg and Rosuvastatin 20mg in fasted state
干预措施: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC (Drug)
Co-administration
Drug: Reference Treatment: Co-administration(Telmisartan 80mg and Rosuvastatin 20mg).
Subjects will receive 1 x Telmisartan 80mg with 1 x Rosuvastatin 20mg tablet administered orally in fasted state as a single dose
干预措施: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC (Drug)
结局指标
主要结局
plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments
时间窗: 0~72hr, 17points
次要结局
未报告次要终点