CTRI/2013/08/003913已完成不适用
Bioequivalence study of Letzmove TM IR/ER tablets, each sustained release tablet containing 150 mg Diclofenac Sodium manufactured by Novartis India Limited compared with Arthrofast tablets, each modified release tablet containing 150 mg Diclofenac Sodium marketed by Novartis Pharma Egypt.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To estimate bioavailability of single dose of Letzmove TM IR/ER tablets, each sustained release tablet containing 150 mg Diclofenac Sodium manufactured by Novartis India Limited compared with Arthrofast tablets, each modified release tablet containing 150 mg Diclofenac Sodium marketed by Novartis Pharma Egypt., using a randomized two way crossover design under fed condition.
研究概览
简要总结
This is a bioequivalence study on Diclofenac Sodium150 mg sustained release tablets. The study will be conducted as a two way, two sequence, randomized, crossover study on twenty four + 2 (stand-by) healthy male human volunteers. The information on the drug, the clinical procedures, the bio-analytical method and requisite regulatory documentation procedures to be followed has been documented.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Ba/be
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •The volunteers will be screened as per Case report form Age & Sex :Adult, Male Between 18 – 45 years Height & Weight:Between ±15% as per Life Insurance Corporation’s of India’s table for ideal height and weight.
- •BMI should fit as per Life Insurance Corporation’s of India’s table for ideal height and weight, preferably between 18-25 kg/m2 Smoking:Non smoker Physical Examination:No evidence of underlying disease.
- •Clinical Examination:No evidence of medical disorders or impairments (Hepatic, renal, cardiac, GIT and psychiatric).
- •No vital sign abnormalities (BP, Pulse etc.) Laboratory Findings:No clinically significant abnormal laboratory values during the pre-study screening.
- •Values for Clinical Biochemistry, Hematology, Liver and Kidneys function tests and Urinalysis in acceptable limits.
- •HIV, Hepatitis B :Negative in screening or non-reactive Cardiac Function:Acceptable ECG Contraindication / Allergy :No history of contraindication and / or allergy to the drug or any related compounds Concurrent / Systemic medication:No consumption of drugs for two weeks prior to the study Drug / Alcohol Abuse:No drug consumed at least 14 days prior to first study drug administration or alcohol at least 48 hours prior to first study drug administration.
- •Participation in Bio-study:Should not have been participated in any Bioavailability or Bioequivalence studies at least 90 days prior to this present study.
- •Volunteer Cooperation:Agrees to abide by the diet and fluid restrictions as required by the study.
- •Agrees to abstain from xanthine containing foods, tobacco and alcohol from at-least 48 hours prior to first drug administration until the follow up examination.
- •Volunteer availability:Agrees to be confined to study center during the study period.
- •Is available for entire study duration for blood sampling or otherwise.
- •Volunteers meeting all the above criteria shall be included in the study after they duly sign the Informed Consent Form.
- •Volunteer who does not meet the above mentioned criteria shall be excluded from the study.
排除标准
- •The volunteers will be excluded based on the following criteria: •History of hypersensitivity to the study drug or related products.
- •â€¢Significant history or presence of psychiatric, gastrointestinal, liver or kidney disorder/impairments, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.
- •â€¢Significant history of asthma, chronic bronchitis or other bronchospastic condition.
- •â€¢Significant history or presence of glaucoma, cardiovascular or hematological disease or diabetes or metabolic acidosis or with a known food allergy.
- •â€¢Significant history or presence of smoking.
- •â€¢Any clinically significant illness during the 4 weeks prior to day one of this study or hospitalized during 3 months prior to the commencement of this study.
- •â€¢Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.
- •â€¢Participation in a clinical trial with an investigation drug within 90 days preceding day 1 of the current study.
- •â€¢Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
- •â€¢Use of any systemic medication (including OTC preparations) within 14 days proceeding day 1 of this study.
- •â€¢Had a depot injection or an implant of any drug 3 months prior to the commencement of this study.
- •â€¢Donated blood (350ml) within 3 months prior to the commencement of this study.
- •â€¢HIV and hepatitis positive findings.
结局指标
主要结局
To estimate bioavailability of single dose of Letzmove TM IR/ER tablets, each sustained release tablet containing 150 mg Diclofenac Sodium manufactured by Novartis India Limited compared with Arthrofast tablets, each modified release tablet containing 150 mg Diclofenac Sodium marketed by Novartis Pharma Egypt., using a randomized two way crossover design under fed condition.
时间窗: 13 days
次要结局
- To estimate bioavailability of single dose of Letzmove TM IR/ER tablets, each sustained release tablet containing 150 mg Diclofenac Sodium manufactured by Novartis India Limited compared with Arthrofast tablets, each modified release tablet containing 150 mg Diclofenac Sodium marketed by Novartis Pharma Egypt., using a randomized two way crossover design under fed condition.
研究者
研究点 (1)
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