Testing P2Y12 platelet inhibitors generics beyond bioequivalence: a parallel single-blinded randomized trial

Thrombosis Journal

Table 1 Comparison between volunteers in Brili and Tica groups on different demographic and baseline laboratory parameters

Parameter	Brili group-brand (N = 14)	Tica group-generic (N = 15)	p-value
No of males (%)	3 (21.4%)	5 (33.3%)	0.682^¥
Age (years)	38.36 ± 7.53	38.80 ± 8.21	0.881^#
BMI (Kg/m²)	31.44 ± 4.95	30.29 ± 4.40	0.513^#
ALT (IU/L)	20.21 ± 9.61	19.33 ± 8.61	0.797^#
Albumin (g/L)	4.20 ± 0.20	4.26 ± 0.28	0.530^#
Scr (mg/dL)	0.72 ± 0.12	0.78 ± 0.14	0.239^#
Hb (10⁶cell/μL)	12.34 ± 1.68	12.67 ± 1.45	0.575^#
PLT (10³cell/μL)	297 ± 82	314 ± 111	0.637^#
ADP Platelet aggregation (%)	69 (48–81)	75 (48–85)	0.06^$
Previous bleeding during or post-surgery (%)	1 (7.14)	0 (0)	0.483^¥

Data are presented as median (range) or mean ± SD for continuous variables and frequency (percentage) for categorical variables
Abbreviation: Brili Brilique®, Tica Ticaloguard®, BMI Body mass index, ALT Alanine transaminase enzyme, Scr Serum creatinine, Hb Hemoglobin, PLT Platelet count, ADP Adenosine diphosphate. P#: Non-significant by independent T-test P$: Non-significant by independent-sample Mann–Whitney U test; P¥: Non-significant by Fisher’s Exact test

ISSN: 1477-9560