A randomized, double-blind, parallel pharmacokinetic study comparing the trastuzumab biosimilar candidate, AryoTrust®, and reference trastuzumab in healthy subjects.

BACKGROUND: AryoTrust® (AryoGen Pharmed Co., Iran) is a biosimilar candidate for the EU-sourced reference trastuzumab, Herceptin®. This study was designed to evaluate the bioequivalence between AryoTrust® and Herceptin®. RESEARCH DESIGN AND METHODS: In this double-blind, parallel study, 60 healthy male subjects were randomized 1:1 to receive a single dose of AryoTrust® or Herceptin® (6 mg/kg) as intravenous infusion. The primary endpoint of the study was the area under the concentration versus time to infinity (AUC0-inf), and the main secondary endpoints were maximum measured concentration (Cmax), area under the concentration versus time from zero to the last quantifiable concentration time (AUC0-last), immunogenicity, and safety. RESULTS: Sixty subjects were enrolled in the study and baseline demographics were similar between the two groups. The two groups demonstrated similar pharmacokinetic parameters and the 90% confidence interval (CI) for primary and secondary endpoints were within the bioequivalence acceptance range (80.00%-125.00%). No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups. CONCLUSION: AryoTrust® was well tolerated, had a similar safety profile to reference trastuzumab, and its pharmacokinetic bioequivalence was confirmed. TRIAL REGISTRATION: The trial is registered at Indian Trials Registry (CTRI/2019/03/018218).

The therapeutic effects of methylphenidate and matrix-methylphenidate on addiction severity, craving, relapse and mental health in the methamphetamine use disorder.

BACKGROUND: Little evidence has examined the therapeutic effects of methylphenidate (MPH) and Matrix Model treatment on addiction severity, craving, relapse and mental health in people who use methamphetamine (PWUM). This study was conducted to determine the effects of MPH, Matrix Model treatment, and Matrix-MPH on addiction severity, craving, relapse and mental health in PWUM. METHODS: This clinical trial was conducted among 100 patients with METH users. Participants were randomly divided into four groups who received: 1) 22 sessions of 45-min, twice a week for Matrix Model treatment (n = 25); 2) MPH 10 mg/day in the first month, 7.5 mg/day in the second month and 5 mg/day in the third month (n = 25); 3) Matrix Model treatment combined with MPH (n = 25); 4) control group (n = 25) for 12 weeks. Addiction severity, craving, relapse and mental status were evaluated at baseline and end-of-trial. RESULTS: Matrix Model treatment combined with MPH significantly reduced MA craving (P < 0.001) and addiction severity (P < 0.001). In addition, Matrix Model treatment combined with MPH resulted in a significant increase of mental health (P = 0.001), compared with Matrix Model treatment, MPH, and control group. Also, negative METH urine test significantly increased in the Matrix Model treatment combined with MPH group compared with the other groups (P < 0.001). CONCLUSIONS: In conclusion, Matrix Model treatment combined with MPH for 12 weeks had beneficial effects on addiction severity, craving, relapse, and mental health in PWUM, compared with Matrix Model treatment, MPH, and control group. TRIAL REGISTRATION: This study was retrospectively registered in the Iranian website ( www.irct.ir ) for clinical trials registration ( http://www.irct.ir : IRCT20171105037245N1 ). Registration date: 9 December 2017.