Human pharmacokinetic research on Cinepazide injection

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2011
INTERVENTION: A:Phase 1, Group A1: 250 mg of Cinepazide mesylate injection Goup A2: 320 mg of Cinepazide maleate injection, once a day for 7 days. Phase 2, wash‐out for 7 days. Phase 3: Group A1: 320 mg of Cinepazide maleate injection Goup A2: 250 mg of Cinepazide mesylate injection, once a day for 7 days. ;B:Three dimensional cross latin square design, the doses are 62.5, 125 and 250 mg per day. ; CONDITION: cerebral infarction PRIMARY OUTCOME: Vital signs, ECG, Count of blood cell, urine analysis, liver and kidney function, blood suger and li; INCLUSION CRITERIA: 1. Male or female subjects aged 18‐45 yrs and the age difference should be less than 10 in one group; 2. Weight>50kg and BMI between 19 to 24 kg/m2; 3. Voluntarily signed the informed consent and having good adherence; 4. Urine pregnancy test is negative.
Epistemonikos ID: b7e1e0e34ddf64dad6ef3cb043717caaa515a1cc
First added on: Aug 22, 2024