A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 50 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin XR Tablet (2 x 500 mg) in Healthy Fed Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 主要终点
- Plasma concentration of canagliflozin following the single dose of drug administration
研究概览
简要总结
The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/500 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.
详细描述
This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications provided to all participants but in different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR) combined in one tablet, in comparison with tablets of individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets). The tablets will be of the same strength (50 mg CANA/500 mg MET XR) and will be compared with the equal doses of the individual drugs: canagliflozin (1 x 100 mg tablet) and metformin XR (2 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components. Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover). The study will consist of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2), an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each (Days -1 through 4) separated by a washout of 10 to 14 days between Day 1 of each Treatment Period, and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure on Day 4 of Treatment Period 3. The total duration of the study will be about 70 days for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 prescription or nonprescription medication (including vitamins and herbal supplements)
- •History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
- •Known allergy to heparin or history of heparin induced thrombocytopenia
- •Donated blood or blood products or had substantial loss of blood within 3 months before screening
研究组 & 干预措施
Treatment A
Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 100 mg, and 2 tablets of metformin extended release (MET XR), 500 mg, administered together under fed conditions.
干预措施: Canagliflozin, 100 mg (Drug)
Treatment A
Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 100 mg, and 2 tablets of metformin extended release (MET XR), 500 mg, administered together under fed conditions.
干预措施: Metformin XR, 500 mg (Drug)
Treatment B
Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions.
干预措施: CANA/MET XR FDC, Formulation 1, 50 mg/500 mg (Drug)
Treatment C
Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions.
干预措施: CANA/MET XR FDC, Formulation 2, 50 mg/500 mg (Drug)
结局指标
主要结局
Plasma concentration of canagliflozin following the single dose of drug administration
时间窗: Predose, (before tablet intake) up to 72 hours afterdose
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
Plasma concentration of metformin following the single dose of drug administration
时间窗: Predose, up to 36 hours afterdose
Plasma concentrations of metformin are used to evaluate how long it 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 period)