Abstract：OBJECTIVE To evaluate the pharmacokinetics and bioequivalence of levomilnacipran hydrochloride sustained release capsules in Beagle dogs. METHODS An open, randomized,two-periods trial design was used. HPLC method was established to determine levomilnacipran hydrochloride in plasma samples of beagle dogs. Pharmacokinetic parameters and bioequivalence were evaluated. RESULTS The pharmacokinetic parameters of levomilnacipran hydrochloride after oral adminstration of test or reference preparations were as follows: ρmax were (394.06±18.22), (384.88±25.65) ng·mL-1; AUC0-72 h were (5 903.86±107.51), (5 396.63±62.63) ng·h·mL-1; AUC0-∞ were (6 325.90±158.88), (6 091.14±121.35) ng·h·mL-1, respectively. The relative bioavailability of F0-72 h(%) and F0-∞(%) of the test/reference formulation were 109.40%, 103.85%; the 90% CIs for the test/reference ratio of ρmax, AUC0-72 h, and AUC0-∞ were 75.11% to 129.61%, 99.35% to 119.44%, and 89.90% to 117.78%, respectively. CONCLUSION The RP-HPLC method is simple, efficient and accurate which can be used for the determination of levomilnacipran hydrochloride plasma concentration. The test capsules are bioequivalent to the reference capsules.
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2020, Vol. 55 
