Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Metformin / Vildagliptin Film Coated Tablets (1000 mg/50 mg) Versus Galvumet® Film Coated Tablets (1000 mg/50 mg)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- AUC 0 - t
研究概览
简要总结
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis.
This study also aims to monitor the safety of the subjects. This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing.
Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height & weight and meeting the selection criteria for this study.
详细描述
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis.
This study also aims to monitor the safety of the subjects. This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing.
Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height & weight and meeting the selection criteria for this study.
Products under investigation for this study:
Test Product: Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia.
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
- Single (Outcomes Assessor)
盲法说明
In this bioequivalence study, the bioanalysis, the pharmacokinetics and the statistical analysis will be blind.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A. The subject is aged between eighteen to fifty years (18 - 50), both inclusive.
- •B. The subject is within the limits for his height & weight as defined by the body mass index (BMI) range (18.5 - 30.0 Kg/m2).
- •C. The subject is able to understand and willing to sign the Informed Consent Form.
- •D. The subject has completed his Coronavirus 19 vaccination schedule. E. The subject is willing to undergo the necessary medical examinations pre- during & post-study.
- •F. There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- •G. The results of medical history, physical examination, vital signs, conducted medical laboratory tests & ECG recording are normal as determined by the investigator.
- •H. The subject tested negative for Hepatitis B (HBsAg) and Hepatitis C (HCVAb). I. For female subjects: negative pregnancy test and the woman is using two reliable contraception methods and should be non-lactating.
- •Non-inclusion Criteria:
- •A. The subject is a heavy smoker (more than 10 cigarettes per day). B. The subject has a history of or concurrent abuse of alcohol. C. The subject has a history of or concurrent abuse of illicit drugs. D. The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
- •E. The subject is vegetarian. F. The subject has suffered an acute illness within seven (7) days before first dosing (declared before inclusion).
- •G. The subject has been hospitalized within three (3) months before the study. H. The subject has taken a prescription medication within two weeks or even an over-the-counter product (OTC) within seven (7) days before first dosing.
- •I. The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing (declared before inclusion).
- •J. The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
- •K. The subject has been participating in any clinical study (e.g. PKs, BA and BE studies) within the last 80 days prior to the present study.
- •L. The subject has donated blood within 80 days before first dosing.
排除标准
- •A. The subject has suffered an acute illness within seven (7) days before dosing (declared after inclusion).
- •B. The subject has been hospitalized during the study. C. The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two (2) days before dosing and until 12 Hrs after dosing in both study periods.
- •D. The subject has taken a prescription medication within two (2) weeks or even an OTC within seven (7) days before first dosing and any time during the study unless otherwise judged acceptable by the investigator.
- •E. The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before dosing (declared after inclusion) and any time during the study.
- •F. The subject underwent a radiological examination with an injection of Iodinated Contrast Media within 48 hours before first dosing.
- •G. The subject has a positive Covid-19 rapid test.
研究组 & 干预措施
First group of healthy volunteers
The first group of healthy volunteers, defined by randomization
干预措施: Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®) (Drug)
First group of healthy volunteers
The first group of healthy volunteers, defined by randomization
干预措施: Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg) (Drug)
Second group of healthy volunteers
The second group of healthy volunteers, defined by randomization
干预措施: Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®) (Drug)
Second group of healthy volunteers
The second group of healthy volunteers, defined by randomization
干预措施: Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg) (Drug)
结局指标
主要结局
AUC 0 - t
时间窗: 0 - 24 Hours
obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: AUC 0 - t.
Cmax
时间窗: 2 - 4 Hours
obtaining the following pharmacokinetic parameters for metformin \& vildagliptin: Cmax.
次要结局
- T half(7 days)
- Tmax(2 - 4 Hours)
- K elimination (λz)(7 days)
研究者
Sameh Trabelsi
MD, Professor in Pharmacology
Reseach Laboratory of Clinical and Experimental Pharmacology