CTRI/2025/11/097344尚未招募不适用
A randomized, open-label, two-treatment, four-cohort, two-period, two-sequence, crossover, single-dose, oral comparative pharmacokinetic and bioequivalence study of Test Product [T: Acetazolamide - PABA cocrystal tablet] of Birla Institute of Technology, India with Reference Product [R: DIAMOX® Tablet (Acetazolamide Tablets I.P. 250 mg] of Sun Pharma Laboratories Ltd., India in healthy adult male human subjects under fasting conditions.
Birla Institute of Technology1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年11月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To compare the pharmacokinetic and bioequivalence of the Test Product [T: Acetazolamide - PABA cocrystal tablet] of Birla Institute of Technology India with Reference Product [R: DIAMOX® Tablet (Acetazolamide Tablets I.P. 250 mg)] of Sun Pharma Laboratories Ltd. India
研究概览
简要总结
This study aims to compare the pharmacokinetic and bioequivalence of the Test Product (T: Acetazolamide - PABA cocrystal tablet) of Birla Institute of Technology India with the Reference Product (R: DIAMOX® Tablet (Acetazolamide Tablets I.P. 250 mg)) of Sun Pharma Laboratories Ltd., India. The study will involve 48 subjects, each housed in a clinical facility for at least 12 hours before dosing and remaining in the facility for at least 24 hours after dosing in each period. The study will also monitor and evaluate the safety of the study subjects. The subjects will be given instructions to swallow the tablets as a whole, with at least 240 mL of drinking water provided. A mouth check will be performed to ensure the subject has swallowed the tablet. After the study, subjects will remain in a sitting position for 04 hours post-dose and only allow necessary movement. Pre-dose and post-dose blood samples will be collected from each subject using pre-labelled K2EDTA containing vacutainers.
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 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Subjects must meet all of the following criteria in order to be included in the study:
- •Subject’s age should be between 18 ¬– 50 years for male.
- •Subjects who are able to read and write the vernacular language (English/Hindi) and understand the study requirements.
- •Must have provided written informed consent for participation in the study in the subject’s vernacular language (English/Hindi).
- •Minimum weight 50.0 kg for male.
- •BMI 18.50 – 29.50 Kg/m
- •Healthy as determined by medical history, physical, clinical and laboratory examination performed within 25 days prior to admission for the first period of the study.
- •In the opinion of the Principal Investigator/Co-Investigator/designee, be able to comply with the study procedures and protocol restrictions.
排除标准
- •Subjects must have none of the following criteria in order to be included in the study:
- •Known hypersensitivity (include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria) or idiosyncratic reaction to (Acetazolamide) or any substituted benzimidazole and its excipients or similar classes of drugs.
- •Any evidence of significant abnormalities upon physical or clinical examination.
- •Laboratory values, which are significantly different from pre-defined reference ranges and judged clinically significant.
- •Consumption of grapefruit juice/ grapefruit at least 48-hours prior to admission in all period of the study.
- •Clinical symptoms of Cyanocobalamin (Vitamin B-12) Deficiency
- •Any clinically significant abnormality in Chest X-Ray PA view or invalid Chest X-ray PA view (after 01 year of validity).
- •Any clinically significant abnormality in ECG.
- •Regular use of tobacco or nicotine in significant amount in any form (e.g. use of equal to or more than 5 cigarettes a day) or have difficulty in abstaining from [smoking] nicotine use for the entire duration of the study.
- •History of drug dependence or excessive alcohol intake on a habitual basis, or, inability to abstain from alcohol for the entire duration of study.
- •History or presence of significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematologic, or endocrine disease.
- •History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc.
- •Positive result for drug(s) of abuse testing (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, morphine, and cocaine) in urine
- •Positive for urine alcohol.
- •History or presence of any psychiatric illness including Symptoms of Depression or mania (Sleep Disturbances, Interest/pleasure reduction, Guilt feelings or thoughts of worthlessness, energy changes/fatigue, concentration/attention impairment, appetite/weight changes, psychomotor disturbances and having thoughts of suicide) and /or intake of any anti-depressant medications.
- •History or presence of any allergic illness including allergic skin diseases, allergic asthma and drug-induced allergy, e.g., NSAIDs.
- •History of intake/administration of any investigational treatment in a clinical study within last 90 days prior to the onset of the study admission of period-I of the study
- •History of significant blood loss (more than or equal to 350 mL) due to any reason, including blood donation within last 90 days prior to admission of period-I of the study.
- •Existence of any surgical or medical condition which in the judgement of principal investigator/designee might interfere with the absorption, distribution, metabolism or elimination of the study drug, or, is likely to compromise the safety of subject.
- •Intake/administration of any enzyme-modifying drugs such as cimetidine, ampicillin, antihistamines, within 30 days of Period I admission.
- •In such cases, subject selection will be at the discretion of the Principal Investigator/medical officer.
- •• Diuretics: Increased risk of hypokalemia and dehydration when used concomitantly with other diuretics.
- •• Salicylates: Increased risk of severe metabolic acidosis and central nervous system toxicity.
- •Salicylates may potentiate the effect of acetazolamide on bicarbonate loss.
- •• Antiepileptic drugs: Acetazolamide may alter serum levels of antiepileptics; dosage adjustment may be needed.
- •• Lithium: Acetazolamide increases lithium excretion, possibly reducing its therapeutic effect.
- •• Amphetamines: May enhance the toxicity of amphetamines by alkalinizing the urine, thereby reducing their excretion.
- •• Methenamine: Acetazolamide alkalinizes urine, reducing the antibacterial efficacy of methenamine, which requires an acidic environment to be effective.
- •• Cardiac glycosides: Electrolyte disturbances (especially hypokalemia) caused by acetazolamide may increase the risk of digoxin toxicity.
- •• Cyclosporine: Concurrent use may increase the risk of nephrotoxicity.
- •Intake/administration of any prescription, antacids or OTC drug including vitamins and natural supplements within 30 days of Period I admission.
- •Intake of unusual diet for two weeks prior to admission of period-I and not willing to avoid consumption of such diet till the completion of close-out visit of the study.
- •In such cases, subject selection will be at the discretion of the Principal Investigator/designee.
- •Difficulty in swallowing tablets.
结局指标
主要结局
To compare the pharmacokinetic and bioequivalence of the Test Product [T: Acetazolamide - PABA cocrystal tablet] of Birla Institute of Technology India with Reference Product [R: DIAMOX® Tablet (Acetazolamide Tablets I.P. 250 mg)] of Sun Pharma Laboratories Ltd. India
时间窗: Samples will be collected at Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50. 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post dose. | Samples at 36.00 and 48.00 hours will be collected at ambulatory sample in both Period | Base line 4 weeks and 8 weeks
次要结局
- Safety of the study subjects will also be monitored & evaluated.(Blood pressure time point - pre-dose (0.00) & at 2.00, 4.00, 6.00, 08.00 & 10.00 hours post-dose. All post-dose vital signs through 10.00 hours will be recorded within ± 40 minutes of the scheduled time for each subject in each period.)
研究者
Dr Shashi Kumar Singh
Mediclin Clinical Services Pvt. Ltd
研究点 (1)
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