Comparative Pharmacokinetic Study of Ramelteon Modified-Release Tablets and Ramelteon Tablets in … (NCT06890715) | Clinical Trial Compass
CompletedPhase 1
Comparative Pharmacokinetic Study of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Healthy Subjects
China12 participantsStarted 2024-06-24
Plain-language 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 subjects Primary objective: To evaluate the bioequivalence of the test product and the reference product by comparing their plasma concentrations and main PK parameters by oral administration in healthy Chinese subjects using Ramelteon Modified-Release Tablets (strength: 8 mg/tablet) developed by Overseas Pharmaceuticals, Ltd. as the test product and Ramelteon Tablets (trade name: Rozerem®, strength: 8 mg/tablet) produced by Takeda Pharmaceuticals America, Inc. as the reference product. Secondary objective: To evaluate the safety of Ramelteon Modified-Release Tablets (test product) and Ramelteon Tablets (reference product) with oral administration after drinking milk in healthy Chinese subjects.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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;
What they're measuring
1
Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)
Timeframe: 1 month
2
Peak concentration at each treatment period (Cmax,tp)
Timeframe: 1 month
3
Area under the curve from time zero to infinity (AUC0-inf)
. 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;