AIM: To assess the bioequivalence of pramipexole hydrochloride tablets with reference (Sifrol). METHODS: A randomized, open-label, 2-period crossover study was conducted in 48 healthy Chinese volunteers under fasted or fed conditions (24 volunteers for each condition). In each session, the subjects received a single oral dose of 0.25 mg test (T) or reference (R) formulation. Pramipexole concentrations in plasma were determined by a validated HPLC-MS/MS. Pharmacokinetic parameters were calculated using a non-compartmental model through Phoenix Win Nonlin version 6.4. Other statistic anal. were analyzed by using software of SAS9.3. RESULTS: The pharmacokinetic parameters of test drug and reference drug under fasted condition (n = 20) were: C_(max) (481.15±102.21) and (497.25±133.31) pg/mL, T_(max)1.77 (0.5, 5) and 1.50 (0.5, 5) h, AUC_(0-t) (6.18±1.49) and (6.20±1.28) pg·mL∼(-1)·h, AUC_(0-∞) (6.41±1.55) and (6.42±1.31)pg·mL∼(-1)·h, T_(1/2) (9.18±1.29) and (9.02±1.14)h, resp. The 90% CIs of T/R for C_(max), AUC_(0-t) and AUC_(0-∞)were 92.20%-103.10%, 94.06%-104.35%, 94.17%-104.07%, all were within the range of 80.00%-125.00%; the two formulations tested were considered bioequivalent when administered under fasted condition to healthy adult subjects. The pharmacokinetic parameters of test drug and reference drug under fedcondition (n = 22)were: C_(max) (515.36 ± 83.28) and (500.05 ± 64.12)pg/mL, T_(max)2.00 (1.00, 4.00) and 1.75 (1.00, 4.00) h, AUC_(0-t) (5.94±1.36) and (5.67±1.05) pg·mL∼(-1)·h, AUC_(0-∞) (6.16±1.43) and (5.88±1.11)pg·mL∼(-1)·h, T_(1/2) (8.92±2.00) and (8.85±1.98)h, resp. The 90% CIs of T/R for C_(max), AUC_(0-t) and AUC_(0-∞) were 97.84%-107.41%, 99.03%-108.79%, 99.12%-108.68%, all were within the range of 80.00%-125.00%. All results meet the cretiria of bioequivance. CONCLUSION: This study suggests that the test formulation of pramipexole hydrochloride tablets are bioequivalent with the reference formulation of Sifrol in Chinese healthy subjects.