CTRI/2024/08/073151尚未招募不适用
An open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover, single oral dose, bioequivalence study of Gabapentin and Nortriptyline hydrochloride tablets of Intas pharmaceuticals Ltd, India with GABATOR NT (gabapentin and nortriptyline tablets) 200 mg+ 10 mg of Torrent pharmaceuticals Ltd, Indrad, Dist. Mehsana, India in normal, healthy, adult, human subjects under fasting condition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cmax,AUC0-t and AUC0-inf
研究概览
简要总结
AN OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWOSEQUENCE,
CROSSOVER, SINGLE ORAL DOSE, BIOEQUIV ALENCE STUDY OF
GABAPENTIN AND NORTRIPTYLINE HYDROCHLORIDE TABLETS OF INT AS
PHARMACEUTICALS LTD, INDIA WITH GABA TOR NT (GABAPENTIN AND
NORTRIPTYLINE TABLETS) 200 MG+ 10 MG OF TORRENT PHARMACEUTICALS LTD,
INDRAD, DIST. MEHSANA, INDIA IN NORMAL, HEALTHY, ADULT, HUMAN SUBJECTS
UNDER FASTING CONDITION
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Non-smoker, Normal, Healthy adult human volunteers between 18 to 45 years of age (both inclusive).
- •Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg I height in m2 • c.
- •Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
- •Able to understand and comply with the study procedures, in the opinion of the investigator.
- •Able to give voluntary written informed consent for participation in the trial.
- •In case of female subjects: I.
- •Surgically sterilized at least 6 months prior to study participation.
- •Or If of child-bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- •Serum pregnancy test must be negative.
排除标准
- •a) Known hypersensitivity or idiosyncratic reaction to Gabapentin or Nortriptyline or to any of its excipients or any drug or any substance.
- •b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal disorder including bleeding or any other body system disorders.
- •c) Ingestion or use of any medication [prescribed & over the counter (OTC) medication including herbal remedies and and CNS depressants including opioids, sympathomimetic agents such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine.) and Cytochrome P450 inhibitors (Cimetidine, methylphenidate)] at any time within 14 days prior to dosing of period-I and any vaccine (including COVID-19 vaccine) from 14 days prior to dosing of period-I.
- •In any such case subject selection will be at the discretion of the Principal Investigator.
- •d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced miicaria.
- •e) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 % distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine in period-I.
- •f) Smokers or who have smoked within last 06 months prior to start of the study.
- •g) The presence of clinically significant abnormal laboratory values during screening.
- •h) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •i) QTc interval more than 450 msec on ECG measurement at the time of screening.
- •j) Subjects with suicidal behavior at the time of screening k) History or presence of seizure or psychiatric disorders.
- •I) A history of difficulty with donating blood.
- •m) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •n) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- •o) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •p) A positive test result for HIV (1 &/or 2) antibody.
- •q) Consumption of Grapefruits or Grapefruit products within a period of 72 hours prior to receiving the study drug in period-I.
- •r) Difficulty in swallowing solids oral dosage forms like tablets or capsules.
- •s) An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug in period-I.
- •t) Nursing mothers (for female subjects).
结局指标
主要结局
Cmax,AUC0-t and AUC0-inf
时间窗: pre-dose (0.000 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 10.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000, 96.000, 120.000 and 144.000 hours
次要结局
- Tmax, AUC %Extrap obs, Lambda-z, R2adjusted & t1/2(pre-dose (0.000 hour) & at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 10.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000, 96.000, 120.000 & 144.000 hours)
研究者
Dr Jogesh Mahajan
Lambda Therapeutic Research Ltd
研究点 (1)
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