CTRI/2026/01/101422尚未招募不适用
An Open Label, Balanced, Randomized, Two-Treatment, Two-Sequence, Four-Period, Full-Replicate, Cross-over, Single Dose Oral Bioequivalence Study of Test Product (T): Duloxetine Delayed-Release Capsules 120 mg Manufactured by Towa Pharmaceutical Europe, S.L., Barcelona, Spain Compared with Reference Product (R): Cymbalta® (Duloxetine) Hard Gastro-Resistant Capsules 60 mg (2 x 60 mg capsules) Marketin Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands in Healthy Adult Male and Female Human Subjects under Fasting & Fed Condition.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
研究概览
简要总结
This study is an open label balanced randomized two treatment two sequence four period full replicate crossover single dose oral bioequivalence study conducted in healthy adult male and female human subjects under fasting & Fed conditions. The primary purpose of the study is to compare the bioavailability of the test product Duloxetine Delayed Release Capsules 120 mg manufactured by Towa Pharmaceutical Europe SL Spain with the reference product Cymbalta Duloxetine hard gastro resistant capsules 60 mg administered as two capsules. The study is designed to evaluate whether the test and reference products are bioequivalent based on pharmacokinetic parameters such as Cmax and AUC. Safety and tolerability of both products will also be assessed throughout the study.
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 Male and Female human subjects aged between 18 years and 45 years (both inclusive) at the time of screening.
- •Having a Body Mass Index (BMI) between 18.50 and 30.00 kg/m2 (both inclusive) at the time of screening.
- •Non-smokers and non-alcoholics
- •Subjects whose clinical laboratory values are within normal limits or clinically insignificant as determined by physician or principal investigator to be of no clinical significance.
- •Normal values/Report in the Suicidal Risk Assessment in the Context of Psychiatric Evaluation during period-I check-in.
- •Have normal ECG, Chest X-Ray and vital signs.
- •Subjects willing to adhere to protocol requirements and provide written informed consent.
- •Male subject should be agreed to use an acceptable contraceptive methods (condoms,gels etc.) from period-I dosing to15 days after the last dose of the study medication as a birth control restriction.
- •Females who are a) Childbearing potential willing to practice an acceptable method of birth control for the duration of the study and for at least 14 days after completion of the study, such as condoms, foams, jellies, diaphragm, intrauterine devices (IUD) or abstinence.
- •b) Surgically sterile (has undergone bilateral tubal ligation, bilateral; oophorectomy or hysterectomy).
- •Non-Pregnant and non lactating females.
排除标准
- •History or evidence of hypersensitivity Duloxetine or any related products or drugs or any of its formulation ingredients.
- •History of gastro-oesophageal reflux disease, peptic ulcer disease or any other related diseases and or any related drugs.
- •Any evidence of impairment of hematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, gastrointestinal, genital, psychiatric disease or disorder.
- •Participation in any clinical research study or any bioavailability bioequivalence study or blood donation within 90 days prior to first dosing of the present study.
- •History of difficulty in donating blood or difficulty in accessibility of veins.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator physician could contraindicate the volunteer participation in the study.
- •History of any difficulty in swallowing of solid oral dosage forms such as capsules.
- •Consumption of caffeine and or xanthine containing food or beverages (like tea, coffee, chocolates or cola drinks or any other) or tobacco containing products (pan masala, gutka, supari, betel nut etc.,) or alcoholic beverage for at least 48 hours prior to study check-in of period-I
- •Consumption of broccoli, Brussels sprouts, St. John’s Wort.
- •char-grilled meat, pomegranate, Seville oranges, star fruit, grapefruit, grapefruit-like or its products containing these foods for at least 07 days prior to check-in of period-I.
- •Received any prescription drugs or over the counter drugs (OTC) (e.g.: Cold preparations, antacid preparations, vitamins and natural products used for therapeutic benefits), or any prescribed medication within 14 days prior to check-in of period-I..
- •Use of any enzyme-modifying drugs prior to 30 days of period-I dosing.
- •Volunteers with positive serology tests.
- •Females with: a) History of amenorrhea or irregular menstrual periods during last 6 months b) Pregnancy or planning to become pregnant or breast feeding during the study c) Usage of hormonal contraceptives either oral or implants d) Positive test results for pregnancy test during screening or at check-in.
研究者
Dr Sanjeeva Reddy K
Admerus Biosciences Private Limited
研究点 (1)
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