CTRI/2024/10/074933已完成1 期
A multicentre, open label, balanced, randomized, two-treatment, two-period, two-sequence, multiple dose, steady state, crossover oral bioequivalence study of Clozapine Orally Disintegrating Tablets 100 mg (Test) of Alkem laboratories Ltd., India with Clozapine Orally Disintegrating Tablets 100 mg (Reference) of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 in patients with Schizophrenia under fasting conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- To demonstrate the bioequivalence between test and reference product under fasting conditions.
研究概览
简要总结
Schizophrenia is one of the most complex and challenging of psychiatric disorders. It represents a heterogeneous syndrome of disorganized and bizarre thoughts, delusions (false beliefs), hallucinations, inappropriate affect, and impaired psychosocial functioning.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult, human, Schizophrenia Patients between 18-65 years of age (including both).
- •Patients who are on a stable regimen of clozapine 100 mg twice daily for at least three months.
- •Patients who are clinically diagnosis of schizophrenia as per DSM-V-TR Criteria (Diagnostic and Statistical Manual of Mental Disorders).
- •Patients who are clinically stable with no hospitalizations of psychiatric symptoms within 03 months prior to screening and randomization.
- •The patient and the legally authorized representative (LAR) must demonstrate adequate decision making ability to make a choice about participating in this study and provide written informed consent to participate.
- •Patients willing to adhere to all the requirements of this protocol.
- •Body mass index in the range of 18.5 to 35.5 kg/m² (≥ 50 Kg for males and ≥48 Kg for females).
- •Normal 12-lead ECG.
- •Normal laboratory parameters during screening.
- •Patient willing to abstain from all kinds of alcoholic beverages, chewing tobacco, pan or pan masala, gutkha masala (containing betel nut and tobacco), having caffeine/xanthine containing foods or beverages (like chocolate, tea, coffee or cola drinks) from 48.00 hours prior to period-01 admission until the last blood sample collection of period-
- •Patients willing to abstain from all kinds of grapefruit (Pomelo, Seville orange etc.) or grapefruit juice containing products, citrus/St. John’s wort containing food and juices from at least 10 days prior to period-01 admission and throughout the study.
- •Male patients willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as Condom with spermicide, Condom with diaphragm, or abstinence.
- •Subjects should also not donate sperm during the study conduct.
- •Female patients: • of child bearing potential willing to practice an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.
- •Or • Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •Patients with a known history of contraindication or hypersensitivity (e.g., anaphylaxis) to Clozapine related class of drugs and any of its ingredients.
- •History of suicidal tendencies (e.g., suicidal attempts) within the past 3 months prior to screening or immediate risk of harm to self or other at the time of screening, as judged by the investigator.
- •Patients with white blood cell (WBC) count below 4000/mm3 or absolute neutrophil count (ANC) below 2000/mm
- •Patients with QTc interval ≥470 msec in male patients or ≥480 msec in female patients.
- •History of QT prolongation, long QT syndrome, family history of long QT syndrome, or family history of sudden cardiac death.
- •Patients with serum potassium less than 3.5 mEq/L or serum magnesium is less than 1.6 mEq/L
- •History of known CYP2D6 poor metabolizers.
- •Use of any prescribed medication or OTC medicinal products including vitamins and herbal drugs within the 2 weeks prior to commencement of the study or at least 5 half lives of the compound whichever period is longer prior to study admission.
- •A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or disease/disorder, dermatological, endocrine, ophthalmic disorder/disease, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
- •Patients positive for HIV HBs Ag or HCV OR VDRL.
- •History of renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion.
- •History or evidence of exfoliative dermatitis, Stevens.
- •Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
- •Patient with history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
- •Patients having concurrent neurological diagnosis, including mental retardation, severe tardive dyskinesia, or idiopathic Parkinson’s disease.
- •Patient had history of narrow-angle glaucoma.
- •Patient with known history of phenylketonuria.
- •Patient had history of multiple syncopal episodes.
- •Any known enzyme inducing or inhibiting drug (like CYP3A4 or CYP1A2 or CYP2D6) taken within 14 days before the study.
- •Participation in a drug research study within 90 days prior to dosing of this study.
- •Blood loss (more than 50 ml) or whole blood donation within 90 days prior to drug administration.
- •Consumption of high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day).
- •A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •Intolerance to venipuncture.
- •History of addiction to any recreational drug or drug dependence.
- •An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study admission of each study period.
- •Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of first period.
- •Positive results for alcohol consumption during the admission of first period.
- •History of pre-existing bleeding disorder.
- •Difficulty in donating blood.
- •Difficulty in swallowing oral solid investigational products.
- •Presence of significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30mmHg or more and/or a drop in diastolic blood pressure of 20mmHg or more on standing), uncontrolled hypertension (systolic BP ≥ 150 mmHg/diastolic BP ≥ 110 mmHg). a. Systolic blood pressure less than 100 mmHg and greater than 150 mm Hg. b. Diastolic blood pressure less than 60 mmHg and greater than 110 mm Hg c. Heart rate less than 60 beats per minute
- •History of alcohol abuse and/or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study.
- •Females with positive results on serum pregnancy test.
- •Females currently breast-feeding.
- •Female patient who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 10 days before dosing.
结局指标
主要结局
To demonstrate the bioequivalence between test and reference product under fasting conditions.
时间窗: Time Points: | Prior to morning dose (within 10 minutes) on days 07, 08, 09 in period 01 and at days 17, 18 and 19 in period 02. | PK sampling days of 10 (in period 01) and 20 (in period 02) will be collected at pre-dose (00.00 hour, within 10 minutes) and at 00.25, 00.50, 00.75, 01.00, 01.33, 01.67, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 07.00, 08.00, 10.00 and 12.00 hours after morning dose.
次要结局
- To monitor the safety and tolerability of Clozapine in patients with Schizophrenia under fasting conditions.(Time Points:)
研究者
Dr Venkateshwarlu Yeldandi
ADVITY Research Private Ltd
研究点 (2)
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