CTRI/2025/03/083410尚未招募不适用
An open-label, balanced, randomized, three-treatment, four-sequence, four-period, single dose, partial replicate, crossover, oral bioequivalence study of Test product 1 (T1), Olsalazine sodium 250 mg (250 mg x 2) capsules (Zuventus Healthcare Limited, India) and Test product 2 (T2), Olsalazine sodium 500 mg (500 mg x 1) capsules (Zuventus Healthcare Limited, India) with Reference product (R), Olsalazine Sodium 250 mg (250 mg x 2) capsules (Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom) in healthy, adult, human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf of Olsalazine from the test product to that of reference product will be assessed.
研究概览
简要总结
Olsalazine is a prodrug administered as an oral once-daily dose. It is converted to mesalamine in the colon, where it exerts its therapeutic effects by potentially reducing inflammation through the inhibition of cyclooxygenase and lipoxygenase pathways, thereby decreasing the production of pro-inflammatory mediators like prostaglandins. This study is designed to demonstrate the bioequivalence between the Test product (Olsalazine sodium 250 mg and 500 mg capsules) of Zuventus Healthcare Limited with the Reference product (Olsalazine sodium 250 mg capsules) of Atnahs Pharma UK Limited, United Kingdom in healthy, adult, human subjects under fasting conditions.
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
- •Healthy adult human subjects between 18-45 years of age (including both)
- •Subjects are able to communicate effectively.
- •Voluntary participation.
- •Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- •Body mass index in the range of 18.5 to 29.9 kg/m² and weight equal to or more than 50 kgs.
- •Normal 12-lead ECG.
- •Normal chest X-ray.
- •Non-smokers and non-alcoholics.
- •Normal laboratory parameters.
- •Subject willing to abstain from all kinds of St John wort or grapefruit or citrus containing foods or juices from 07 days prior to admission until the last post dose blood sample collection in each study period and caffeine/xanthine containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) from 72.00 hours prior to admission until the last post dose blood sample collection in each study period.
- •Female subjects of childbearing potential practicing an acceptable method of birth control for the duration of the study and willing to practice an acceptable method of birth control for 05 days after last dose 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
- •Volunteers with a known history of contraindication or hypersensitivity (e.g., anaphylaxis) to olsalazine or related class of drugs and any of its ingredients.
- •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 psychiatric disease/disorder, dermatological, endocrine, immunological, hepatic impairment (such as Child-Pugh Class C), renal impairment, 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.
- •History or presence of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine
- •History or evidence of exfoliative dermatitis, Stevens Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
- •Any known enzyme inducing or inhibiting drug taken within 14 days before the study.
- •Participation in a drug research study within 90 days prior to dosing of this study.
- •A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •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 each study period.
- •Intolerance to venipuncture.
- •Difficulty with donating blood.
- •Difficulty in swallowing investigational products.
- •Blood pressure on the day of admission of each study period.
- •Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
- •Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •Use of any prescribed medication or OTC medicinal products including vitamins and herbal drugs within the 2 weeks or at least 5 half-lives of the compound whichever period is longer prior to commencement of the study.
- •History of alcohol abuse and/or dependence within six months of 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 volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used oral hormonal contraceptives within 14 days before dosing.
结局指标
主要结局
Pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf of Olsalazine from the test product to that of reference product will be assessed.
时间窗: Pre-dose (00.00 hour) and 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post-dose.
次要结局
- Assessment of safety of single oral dose of test and reference product.(Through-out the study period)
- Pharmacokinetic parameters Tmax, T1/2, Kel and AUC_%Extrap of Olsalazine from test products to that of reference product will be assessed.(Pre-dose (00.00 hour) and 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post-dose.)
研究者
Dr Bhupesh Dewan
Zuventus Healthcare Limited
研究点 (1)
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