AN OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, CROSSOVER, SINGLE ORAL DOSE, BIOEQUIVALENCE STUDY OF MELOXICAM GSK 15 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND MOBIC® 15 MG TABLETS OF BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG BINGER STR.173, 5521 INGELHEIM AM RHEIN, GERMANY, IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FED CONDITION.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Maximum Drug Concentration During the Selected Dosing Interval (Cmax) After a Single Dose
研究概览
简要总结
It is a randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study of Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.Cc, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy, adult, human male subjects under fed condition. It is a pivotal study to demonstrate the bioequivalence of Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH & Co.KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy adult human male subjects under fed condition.
This study will enroll 28 healthy adult human male subjects
详细描述
The objectives of this study are to:
To demonstrate the bioequivalence of Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH & Co.KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy adult human male subjects under fed condition To monitor the safety of the study subjects. Study design: A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fed condition. It is a pivotal study Sample size estimation: Based on the literature available [Public assesment report Scientific Discussion Meloxicam "Arrow" Tablets 7.5 and 15 mg Meloxicam, DK/H/0905/001-002/MR] sample size of 28 subjects will be enough to meet the study objective. And 28 healthy adult human male subjects will be enrolled.
Screening procedures:
Demographic data, medical and medication histories, complete physical examination, height, weight and BMI as well as 12 lead ECG, chest X-ray [PA view], vital signs [blood pressure, pulse rate, respiratory rate and oral temperature], hematology, biochemistry, HIV1& 2, Hepatitis B and C, RPR test for Syphilis and urine analysis will be done at screening.
Urine drug screen, Liver chemistry test and Breath alcohol test to be done prior to each check-in.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male human subjects within the age range of 18 to 45 years inclusive.
- •Heght not less than 50 kg.
- •Normal BMI [18.5 to 24.99 kg/m2 inclusive].
- •Willingness and capability to provide written informed consent to participate in the study.
- •Free of significant diseases or clinically significant abnormal findings based on medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray [PA view].
- •Absence of disease markers of HIV 1 and 2, Hepatitis B and C and Syphilis.
- •AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •ECG normal for morphology and measurements. QTcB or QTcF < 450 msec or QTc < 480 msec in subjects with Bundle Branch Block, based on an average from three ECGs obtained over a brief recording period.
- •Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed below. This criterion must be followed from the time of the first dose of study medication until one week of last dose administration.
- •Condom plus partner use of a highly effective contraceptive such as occlusive cap (diaphragm or cervical/vault cap) plus spermicidal agent (foam/gel/film/cream/suppository), oral contraceptive, injectable progesterone, implant of etonogestrel or levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, or intrauterine device.
- •Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
排除标准
- •History or presence of significant: Cardiovascular, pulmonary, hepatic, renal, hematological, gastro-intestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease.
- •History or presence of significant:
- •Alcohol dependence or alcohol abuse during past one year.
- •Drug abuse [Marijuana [THC], Cocaine, Morphine, Benzodiazepines, Barbiturates and Amphetamine] for the last 6 months.
- •Smoking of more than 5 cigarettes per day or consumption of other forms of tobacco containing products.
- •Asthma, urticaria or other allergic type reactions after taking aspirin or any other drug.
- •Ulceration or history of gastric and / or duodenal ulcer.
- •Jaundice in the past 6 months.
- •Bleeding disorder.
- •Allergy to the test drug or any drug chemically similar to the drug or to the excipients of the products under investigation.
- •Donation of 500 mL or more blood within 8 weeks prior to receiving the first dose of study drug.
- •The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •Any difficulty in accessibility of forearm veins for cannulation or blood sampling.
- •Refusal to consume high calorie high fat breakfast 30 minutes before scheduled dosing time and abstain from food for at least 5 h post dose in each period.
- •Refusal to abstain from fluid for at least 1 h prior to and 1 h post each dose.
- •Positive breath alcohol test result found on the day of check-in.
- •Positive urine test result for drug of abuse found on the day of check-in.
- •History of difficulty in swallowing tablet.
- •Use of any concomitant medication [including over-the-counter products, vitamins etc.] for 14 days preceding the study drug administration.
- •Use of drugs which induce or inhibit metabolizing enzymes within 30 days prior to receiving the first dose of study medication.
研究组 & 干预措施
Meloxicam GSK 15mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fed condition
干预措施: Meloxicam GSK 15mg (Drug)
Meloxicam GSK 15mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fed condition
干预措施: Mobic 15mg (Drug)
Mobic 15mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fed condition
干预措施: Meloxicam GSK 15mg (Drug)
Mobic 15mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fed condition
干预措施: Mobic 15mg (Drug)
结局指标
主要结局
Maximum Drug Concentration During the Selected Dosing Interval (Cmax) After a Single Dose
时间窗: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period
Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. The Cmax was taken directly from the plasma concentration-time profile of individual participants
Time to Maximum Concentration (T-max)
时间窗: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The Tmax was taken directly from the plasma concentration-time profile of individual participants. Plasma samples for PK analysis were drawn at indicated time points.
The Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose
时间窗: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC(0-t) was area under the plasma concentration-time curve from time of administration until the time of last quantifiable concentration. The area under the plasma concentration-time curve (AUC0-infinity), was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.
The Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUCpercentage [%]_Extrap [Residual Area]) After a Single Dose
时间窗: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The percentage of area under curve extrapolated to arrive at AUC0-infinity (AUC%_Extrap \[residual area\]) was determined by AUC0-infinity minus AUC0-t divided by AUC0-infinity multiplied by 100.
Elimination Rate Constant (Kel) After a Single Dose
时间窗: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semilogarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.
Elimination Half Life (T-half) After a Single Dose
时间窗: Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period
The T-half was calculated using the following formula by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.
次要结局
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(Up to 20 days)