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Exposures of paliperidone in specific populations (renal impairment, hepatic impairment and elderly) are summarized in Figure 3 [see DOSAGE AND ADMINISTRATION and Use In Specific Populations ]. After oral administration of paliperidone in patients with moderate hepatic impairment, the plasma concentrations of free paliperidone were similar to those of healthy subjects, although total paliperidone exposure decreased because of a decrease in protein binding. Paliperidone has not been studied in patients with severe hepatic impairment [see Use In Specific Populations ]. After oral administration of paliperidone in elderly subjects, the Cmax and AUC increased 1. However, there may be age-related decreases in creatinine clearance [see DOSAGE AND ADMINISTRATION and Use In Specific Populations ]. Figure 3: Effects of intrinsic factors on paliperidone pharmacokinetics. Based on in vitro studies utilizing human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone. Slower absorption was observed in females in a population pharmacokinetic analysis. At apparent steady-state with INVEGA TRINZA ‘ , the trough concentrations were similar between males and females. Lower Cmax was observed in overweight and obese subjects. At apparent steady-state with INVEGA TRINZA ‘ , the trough concentrations were similar among normal, overweight, and obese subjects. Animal Toxicology And/Or Pharmacology. Injection site toxicity was assessed in minipigs injected intramuscularly with the 3-month paliperidone palmitate extended-release injectable suspension at doses up to 819 mg, which is equal to the MRHD. Injection site inflammatory reactions were greater and more advanced than reactions to the 1-month paliperidone palmitate extended-release injectable suspension. Reversibility of these findings was not examined. The efficacy of INVEGA TRINZA ‘ for the treatment of schizophrenia in patients who have been adequately treated for at least 4 months with INVEGA SUSTENNA ‘ (1-month paliperidone palmitate extended-release injectable suspension) was evaluated in a long-term double-blind, placebo-controlled randomized-withdrawal trial designed to evaluate time to relapse involving adult subjects who met DSM-IV-TR criteria for schizophrenia, tamoxifen 20 mg substitute. Patients could enter the study with acute symptoms (if previously treated with oral antipsychotics) or be clinically stable (if treated with long-acting injectable antipsychotics [LAI]). 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