Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Fasting group A:Cycle I: Test preparation
Cycle II: Reference preparation
Fasting group B:Cycle I: Reference preparation
Cycle II: Test preparation
Sponsors
Wuhan Xiangfang Specialty Clinical Pharmacology Research Center
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers; 2. Age: 18 to 40 years; 3. Gender: Female 4. Weight: not less than 45kg; body mass index [= weight kg / (height m) 2] is between 19 and 27 (including boundary value); 5. General physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, blood human chorionic gonadotropin / urinary pregnancy, etc.), ECG, etc. are normal; 6. 90mmHg <= systolic blood pressure <140mmHg, 60mmHg <= diastolic blood pressure <90 mmHg, normal blood pressure 7. Voluntarily participate in the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those with a history of drug abuse and obvious tobacco and alcohol addictions; 2. Participants in other drug trials within 3 months; 3. Patients with abnormal clinical manifestations, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone and other system diseases; 4. Those who have taken any drug in the past 2 weeks; 5. People with a history of drug allergy; 6. Subjects who were believed that the compliance is poor, or have any factors that are not suitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration of permalidomide; | — |
Countries
China
Contacts
Public ContactWeiyong Li
Outcome results
None listed