Status:
COMPLETED
Comparative Pharmacokinetic Study of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Healthy Subjects
Lead Sponsor:
Overseas Pharmaceuticals, Ltd.
Collaborating Sponsors:
Beijing CTSmed Co. Ltd
Conditions:
Chronic Insomnia Characterized
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
A randomized, open-label, two-period, double-crossover comparative pharmacokinetic (PK) study of a single oral dose of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Chinese healthy subje...
Detailed Description
The trial was divided into screening period, period I, period II and safety follow-up period. The washout period is 2 days during the period. Screening period: All subjects must sign an informed cons...
Eligibility Criteria
Inclusion
- Healthy male and female subjects aged 18 to 45 years (including 18 and 45 years);
- Male subjects with a body weight ≥ 50.0 kg, and female subjects with a body weight ≥ 45.0 kg; BMI (BMI = body weight (kg)/\[height (m)\]2) within the range of 19-26.0 kg/m2 (including the critical value);
- Subject who fully understands the purpose, nature, method and possible adverse reactions of the study, voluntarily acts as a subject, and signs informed consent prior to the commencement of any study procedure;;
- Subjects who are able to communicate well with the investigator and understand and adhere to the study requirements.
Exclusion
- Subjects with an allergic history to the study drug or other melatonin or any other component of the study drug, or an allergic history to drug, food , pollen or a specific allergic history (asthma, allergic rhinitis);
- Subjects who have special dietary requirements and cannot accept a unified diet;
- Subjects with a history of dysphagia or any gastrointestinal disorder affecting drug absorption;
- Subjects who cannot tolerate venipuncture , or with needle fainting or blood collection difficulties;
- Subjects with clinically significant hematological, endocrine, cardiovascular, hepatic, renal and pulmonary disorders that may affect drug absorption, distribution, metabolism and excretion;
- Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, coagulation four, pregnancy test (female), etc.), 12-lead electrocardiogram, chest X-ray examination results judged by researchers to be clinically significant;
- Subjects with a surgical history within the 3 months prior to the study or taking the study drug or who plan to have surgery during the trial ；
- Those who received the vaccine within 28 days before the first dose； 9) Subjects with blood donation or massive blood loss (\> 450 mL) within 3 months before the study;
- 10\) Subjects taking special diet (including pitaya or grapefruit and products containing grapefruit ingredients) or having strenuous exercise within 7 days before taking the study drug, or having other factors affecting drug absorption, distribution, metabolism and excretion; 11) Subjects administered with any prescription drugs, over-the-counter, herbal, or health products within 14 days prior to taking the study drug; 12) Drug users with a history of interaction with rametylamine tablets within 30 days prior to screening (fluvoxamine, rifampicin, ketoconazole, fluconazole, Donepezil, doxepin, Zolpidem, etc.; 13) Regular drinkers within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirit containing 40% alcohol or 150 mL of wine); 14) Subjects who have a history of smoking in the first 3 months of prior to screening; Or who cannot stop using any tobacco products during the test period; Or positive results of tobacco test; 15) Subjects who have consumed chocolate, any caffeine-containing, or xanthine-rich food or beverage, such as coffee, strong tea, and cola 48 h before taking the study drug; 16) Subjects having taken any alcohol-containing products within 48 h before taking the study drug, or having a positive result for alcohol screening; Subjects positive for drug screening or with a history of drug abuse within the past five years or using drugs 3 months before the trial; 17) Female subjects with positive pregnancy test or lactating during the screening period or during the trial;Subjects (including male subjects) had a birth plan or could not use effective contraception from 2 weeks before the trial screening to 1 month after the trial ended; 18) Subjects positive for HBsAg, HCV-Ab, anti-HIV or primary syphilis screening; 19) Subjects who have participated in other clinical trials and used experimental drugs or devices within 3 months prior to screening; 20) Subjects with underlying medical, psychiatric, psychological or other discomfort conditions, poor compliance, or who, as judged by the investigator, are not suitable for the study.
Key Trial Info
Start Date :
June 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06890715
Start Date
June 24 2024
End Date
July 8 2024
Last Update
March 24 2025
Active Locations (1)
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1
clinical trial centre of Medical ethics committee of Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510700