An Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics of Canagliflozin (JNJ-28431754) and Metformin Following Once-Daily Administration of 2 Canagliflozin/Metformin XR (150/1,000-mg) Fixed Dose Combination Tablets in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets
研究概览
简要总结
The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2 Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150 mg/1,000 mg each) following once-daily oral dosing in healthy participants.
详细描述
This is an open-label (physicians and participants know the identity of the assigned treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination (FDC) of 150 mg/1,000 mg Canagliflozin/extended release Metformin (CANA/MET XR) tablets. The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase, (when the participants will be confined to the study center for 11 days), and a Follow-up Phase of about 10 days. The total duration of the study will be about 42 days for each participant. During the Open-Label Treatment Phase, approximately 12 healthy adult participants will receive a single oral dose of 2 CANA/MET XR tablets once daily for 7 days after a provided dinner. Participants will be required to fast from the end of lunch until the dinner (a period of at least 6.5 hours) on Days 1 and 7 only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must sign an informed consent document indicating they understand the purpose of the study and procedures
- •Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
- •Must have a body weight of not less than 50 kg
- •Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
- •Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)
排除标准
- •History of or current clinically significant medical illness
- •Use of any systemic prescription or nonprescription medication (including vitamins and herbal supplements)
- •Known allergy to canagliflozin or metformin or any of the excipients of the formulation
- •Known allergy to heparin or history of heparin induced thrombocytopenia
- •History of smoking or use of nicotine-containing substances within the previous 2 months
研究组 & 干预措施
Canagliflozin/Metformin XR
Each patient will receive 2 tablets of CANA/MET XR combination of total dose 300/2000 mg
干预措施: CANA/MET XR FDC (Drug)
结局指标
主要结局
Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets
时间窗: Day 1, Day 7
Plasma concentrations of metformin are used to evaluate how long it stays in the body.
Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets
时间窗: Day 1, Day 7
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
次要结局
- Percentage of participants with adverse events as a measure of safety and tolerability(Screening, up to Day 10 of the follow-up)