severe but reversible muscle spasms, caused by multiple sclerosis
Conditions
Interventions
Group A:Twenty-two fasting participants were randomized 1:1 into Groups A and B. Group A received the test formulation (T) in the first period under fasting conditions, followed by a 3-day washout, an
Group B:Twenty-two fasting participants were randomized 1:1 into Groups A and B. Group B received the reference formulation (R) in the first period under fasting conditions, followed by a 3-day washou
Group C:Twenty-two participants were randomized 1:1 into Groups C and D under fed condition. Group C received the test formulation (T) in the first period under fed conditions, followed by a 3-day was
Group D:Twenty-two participants were randomized 1:1 into Groups C and D under fed condition. Group D received the reference formulation (R) in the first period under fed conditions, followed by a 3-da
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Gender: both male and female healthy subjects; 2. Age: 18 years old and above (including 18 years old); 3. Weight: Male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, body mass index [BMI= weight (kg)/height 2 (m2)] within the range of 19.0~26.0kg/m^2 (including boundary values); 4. The subjects must give informed consent to the study before the experiment, and voluntarily sign a written informed consent; 5. The subject is able to communicate well with the investigator and complete the study in accordance with the study regulations.
Exclusion criteria
Exclusion criteria: 1. Allergic, allergic to baclofen and its related compounds and excipients, or allergic to two or more drugs (or food); 2. Those who cannot follow a unified diet (such as intolerance to standard meals, etc.) or have difficulty swallowing; 3. Patients who cannot tolerate venipunction and have a history of fainting needles and blood; 4. Those who have or currently suffer from important diseases of the circulatory system, respiratory system, digestive system, blood system, nervous system, immune system, urinary system, endocrine system and mental system, have any condition that may significantly affect drug absorption, distribution, metabolism and excretion or have a history of surgery, or suffer from hemorrhagic diseases (such as gastrointestinal ulcers, hemorrhagic stroke, etc.); 5. Those who have undergone major surgery within the 6 months prior to screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion (except appendicitis surgery); 6. Physical examination, vital signs monitoring, electrocardiogram examination, chest low-dose CT examination, laboratory examination (blood routine, urine analysis, blood biochemistry, coagulation function, blood pregnancy (only for female subjects), etc.) during the screening period, if the investigator judged the abnormality to be clinically significant; 7. Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody or HIV antibody test results abnormal clinical significance; 8. Drink excessive (more than 8 cups a day, 1 cup =200mL) tea, coffee or caffeinated beverages within 3 months before screening; Or ingested any food or drink containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first dose of the study; 9. In the 48 hours prior to the first administration of the study, any beverage or food rich in xanthine or grapefruit components or other substances that affect drug absorption, distribution, metabolism, excretion, etc.; 10. Used any drugs that interact with baclofen (such as levodopa/dopa decarboxylase (DDC) inhibitors, central nervous system (CNS) inhibitors, antidepressants, lithium, antihypertensive drugs, drugs that impair renal function, etc.) within 28 days before screening; 11. Patients who have used long-acting estrogen or progesterone injections or implants within 6 months before screening; Use of short-acting contraceptives within 30 days prior to the trial; 12. Participants who had used any prescription drugs, non-prescription drugs, Chinese herbs or health care products within 14 days before the first medication; 13. Smokers who smoked more than 5 cigarettes per day within 3 months before signing the informed consent, and those who smoked from enrollment to the whole test period could not accept prohibited smokers; 14. A positive alcohol breath test prior to the first dose of the study, or drinking more than 14 standard units per week in the 6 months prior to screening (1 standard unit containing 14g of alcohol, such as 360mL beer or 45mL spirits with a 40% alcohol breath or 150mL wine); 15. Positive urine drug screening before the first drug use in the study or a history of drug abuse (such as morphine, cannabis, methamphetamine, dimethylene dioxyamphetamine, ketamine, etc.) within 1 year before the test; 16. Pregnant or lactating women, and male subjects (or their partners) or female subjects who planned to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peak plasma concentration (Cmax);The area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t);the area under the curve from time zero to infinity (AUC0-8); | — |
Secondary
| Measure | Time frame |
|---|---|
| time to peak concentration (Tmax);of the elimination half-life (t1/2) ; | — |
Countries
China
Contacts
Public ContactHan Yangyun; Fan Lianlian
Deyang People's Hospital
Outcome results
None listed