NCT07691203已完成1 期
An Open Label, Randomized, Two-period, Two Treatment, Two-sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study to Compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR (Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-release Tablets) 25 mg/5 mg/1000 mg in Fed Condition.
Humanis Saglık Anonim Sirketi1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年3月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- For Empagliflozin & Linagliptin & Metformin; Maximum concentration obtained (Cmax)
研究概览
简要总结
An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) in healthy subject in fed 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 to 55 years old, both inclusive.
- •Gender: Male and/or non-pregnant, non-lactating female. A. Female of child-bearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days of the first dose of study medication. They used an acceptable form of contraception.
- •For female of child-bearing potential, acceptable forms of contraception included the following:
- •i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
- •B. Females were not considered of child-bearing potential if one of the following was reported and documented on the medical history:
- •i. Postmenopausal with spontaneous amenorrhea for at least 12 consecutive months without other medical explanation, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months.
- •18.5 to 30.0 kg/m2, both inclusive; BMI values were rounded off to one significant digit after decimal point (e.g. 30.04 rounded down to 30.0, while 18.45 rounded up to 18.5).
- •Able to communicate effectively with study personnel.
- •Non-alcoholic, non-smoker and non-tobacco user (i.e. had no past history of drinking alcohol, smoking and tobacco consuming for at least one year prior to study).
- •Normal or clinically non-significant ECG recording during screening.
- •Willing to provide written informed consent to participate in the study.
- •All participants were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which included: a) A physical examination (clinical examination) with no clinically significant finding.
排除标准
- •History of allergic responses to Empagliflozin, Linagliptin, Metformin or other related drugs, or any of its formulation ingredients.
- •Had significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female participants)].
- •Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, Central nervous system or any other body system.
- •History or presence of bronchial asthma.
- •Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
- •Used any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
- •History or evidence of drug dependence.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •A positive hepatitis screen (included subtypes B & C).
- •A positive test result for HIV antibody.
- •Participant who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
- •Participant who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever was greater.
- •History of difficulty in swallowing or of any gastrointestinal disease, which affected drug absorption.
- •Intolerance to venipuncture.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the participant's participation in this study.
- •Institutionalized participant.
- •Used any prescribed medications within 14 days prior to the first dose of study medication.
- •Used any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- •Used grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- •Ingested any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication.
- •Ingested any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- •Presence of ketone during urine analysis.
- •History or presence of cardiovascular disorders.
- •Participant with Serum Lactate higher than upper limit of normal range.
- •Participant with Estimated Glomerular Filtration Rate was less than 60 ml/min/1.73 m2 during screening.
- •History or presence of hypoglycemia.
- •Participant with Serum Creatinine higher than upper limit of normal range.
- •History of acute and chronic metabolic acidosis.
- •History or sign and symptoms of pancreatitis.
- •History of genital mycotic infections.
- •History of severe and disabling arthralgia.
- •History of bullous pemphigoid.
- •History of recurrent urinary tract infection
结局指标
主要结局
For Empagliflozin & Linagliptin & Metformin; Maximum concentration obtained (Cmax)
时间窗: Empagliflozin & Metformin; 48 hours, Linagliptin; 72 hours
two-sides 90% CI for the test to reference ratio of the population means is within 80.00-125.00% for each of the Ln-transformed data Cmax
For Empagliflozin & Metformin; AUC from time 0 to last collection time (AUC0 - t)
时间窗: Empagliflozin & Metformin: 48 hours
two-sides 90% CI for the test to reference ratio of the population means is within 80.00-125.00% for each of the Ln-transformed data AUC
For Linagliptin; Area under the plasma concentration-time curve from 0 to 72 hours (AUC72)
时间窗: 72 hours
two-sides 90% CI for the test to reference ratio of the population means is within 80.00-125.00% for each of the Ln-transformed data AUC
次要结局
- For Empagliflozin & Linagliptin & Metformin; Time to reach maximum concentration Cmax (Tmax)(Empagliflozin & Metformin: 48 hours, Linagliptin: 72 hours)
- For Metformin : Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration(AUCt)(48 hours)
- For Empagliflozin: Area under the plasma concentration versus time curve from zero to infinity (AUCi)(48 hours)
研究者
研究点 (1)
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