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Largely due to population ageing, the cancer burden from older people has been rising, which imposed considerable pressure on current Chinese healthcare system. We provide comprehensive information about cancer burden of Chinese older people based on the most recent data from National Central Cancer Registry of China. The logarithmic linear regression was used to project the current cancer burden in 2022, and Joinpoint regression was used for temporal trend analysis from 2000 to 2017. We also estimated cancer statistics of older people in the US, Japan and the Republic of Korea for comparisons. It is estimated that 2.79 million cases and 1.94 million deaths occur for Chinese older people, representing 55.8% and 68.2% of cases and deaths in all population in 2022. The overall cancer incidence rate gradually increased among older women, while the mortality rates declined for both sexes. Notably, approximately 10.0% of all cases and 17.7% of all deaths are from people aged over 80 years, and cancer incidence and mortality in this age group showed upward trends for women. Lung cancer and digestive cancers are the leading cancer types for Chinese older people. Compared with other countries, China has lower incidence rates but higher mortality rates for older people. The rapidly growing burden of prostate cancer, breast cancer, colorectal cancer, and declines in esophageal cancer, stomach cancer, and liver cancer among older people indicate the cancer pattern in China is being in a transition stage to that in developed countries. Our findings imply that it should be the national health priority to meet the growing demands for cancer diagnosis, treatment and care services from the older people as the rapid population ageing in next few decades., (© 2022. Science China Press and Springer-Verlag GmbH Germany, part of Springer Nature.)

Combination therapy with diuretics and angiotensin II type 1 (AT1) receptor antagonist is frequently recommended for the control of blood pressure in hypertensive patients. This study was targeted to compare pharmacokinetic profiles of a new generic fixed-dose combination (FDC) tablet of olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg and a reference formulation of Olmetec Plus 20/12.5 mg tablets in healthy volunteers. The study design was a randomized sequence and two-way crossover study in healthy subjects. They were to be randomly assigned to either one of the two sequence groups; each subject sequentially received a single oral dose of reference and test tablet with 7-day washout period. Blood sample was collected at pre-dose and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 h post-dose. The blood concentrations were analyzed by LC-MS/MS. Both of the 90% CI for the treatment ratios (test/reference) of C(max) and AUC(last) were to be in the range of 0.800-1.250 with regards to olmesartan medoxomil and hydrochlorothiazide; the geometric mean ratios (test/reference) for olmesartan C(max) and AUC(last) were 0.979 (90% CI, 0.934-1.027) and 0.992 (0.946-1.041), respectively, and those for hydrochlorothiazide C(max) and AUC(last) were 0.966 (0.975-1.110) and 0.999 (0.963-1.038), respectively. No serious adverse events were reported during the study. The generic formulation of olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg tablet was bioequivalent with the reference formulation of Olmetec Plus 20/12.5 mg tablet in regards to the pharmacokinetic parameters of olmesartan medoxomil and hydrochlorothiazide. Clinical Research Information Service (CRIS) Registration Number: KCT0001025. (https://cris.nih.go.kr/ Mar 18, 2014)

Background: Acetyl-L-carnitine (ALC) has demonstrated neuroprotective effects in several experiments and is widely prescribed to reduce cognitive impairment in Alzheimer's disease patients or manage neuropathic symptoms in diabetic patients., Objectives: This study was designed to assess the pharmacokinetic (PK) bioequivalence between a new generic (test) formulation of ALC hydrochloride 590 mg and a branded (reference) formulation of ALC hydrochloride 590 mg in healthy Korean male volunteers., Methods: This was a randomizedsequence, single-dose, two-way crossover study. All subjects randomly received one formulation of the test or reference tablet and the other formulation with a 7-day washout period. Blood samples (7 mL) were collected immediately before dosing, and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours postdose. The plasma concentrations of ALC were analyzed using liquid chromatography tandem mass spectrometry. Tolerability was assessed throughout the study., Results: The PK profiles of both formulations showed similar rends. The mean (±SD) baseline (predose) concentration of ALC was 1.23±0.31 μg/mL and 1.09±0.30 μg/mL for the test and the reference formulations, respectively. The mean Cmax for the test and reference formulations were 1.74±0.43 μg/mL and 1.68±0.48 μg/mL, respectively. The mean AUClast of ALC was 12.96±1.89 μg×h/mL and 12.49±2.44 μg×h/mL for the test and reference formulations, respectively. The geometric mean ratios of test/reference (90% CI) were 1.050 (0.960-1.149) for Cmax and 1.048 (1.000-1.099) for AUClast. Both formulations were well tolerated in all treatment groups., Conclusion: The test and the reference formulations of ALC were bioequivalent with regard to the PK parameters.

Background: Tianeptine is widely used for controlling depressive symptoms., Objective: The aim of this study was to evaluate the bioequivalence between the generic (test) formulation containing tianeptine sodium 12.5 mg and the branded (reference) formulation Stablon® with regard to their pharmacokinetic profiles., Methods: A randomized, two-sequence, two-treatment crossover study was conducted in healthy male Korean volunteers. All of the enrolled subjects were allocated to one of two sequence groups. They were administered a tablet of the test or reference formulation and then administered the alternative formulation after a 7-day washout period. The blood samples were taken before dosing and at 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 10 hours after dosing. The plasma concentrations of tianeptine were analyzed using high-performance liquid chromatography with tandem mass spectrometer. Tolerability was assessed throughout the study., Results: The pharmacokinetic parameters were assessed in the 40 subjects who completed the study. The tianeptine C(max) for the test formulation was 283.13 ± 57.58 ng/mL (mean ± SD) and that for the reference formulation was 272.50 ± 59.00 ng/mL. The AUC(last) of tianeptine was 803.24 ± 180.94 ng×h/mL for the test formulation and 792.27 ± 180.93 ng×h/mL for the reference formulation. The geometric mean ratio (%) of the test to reference formulation was 104.04 (90% CI, 99.66 - 108.61) for C(max) and 101.30 (98.01 - 104.71) for AUC(last). Clinically significant adverse events were not reported during the study., Conclusion: The test and reference formulations of tianeptine were bioequivalent with regard to the pharmacokinetic parameters of Cmax and AUC(last). Both formulations were tolerated by all of the participants.

Background: A sildenafil tablet formulation as a PDE-5 inhibitor is widely used for the treatment of erectile dysfunction. Recently, a fine granular formulation of sildenafil was developed by a domestic Korean pharmaceutical company., Objectives: This study was performed to compare the bioavailability of sildenafil fine granules with that of sildenafil tablets for assessing bioequivalence in 40 healthy male volunteers., Methods: This was an open-label, randomized sequence, single-dose, two-period, and two-treatment crossover study. Half of the volunteers received a single dose of sildenafil fine granule 50 mg and then sildenafil tablet 50 mg after a 7-day washout period. The remaining half of volunteers received the tablet first and the the granule with the same washout period. 10- mL blood samples were serially sampled to measure the concentrations of sildenafil and the N-desmethyl metabolite. Tolerability was assessed during the study., Results: The pharmacokinetic parameters of sildenafil were similar between granular and tablet formulations. The 90% CI of geometric mean ratios (sildenafil granule/tablet) for the pharmacokinetic parameters of sildenafil were within 0.8 – 1.25, as a bioequivalent acceptable range; 1.111 (90% CI, 1.002 - 1.231) for maximum plasma concentration (Cmax) and 1.092 (1.019 - 1.117) for area under the concentration- time curve from time zero to time of last measurable concentration (AUClast). Also, the 90% CI of geometric mean ratios for Cmax and AUClast of the metabolite were within 0.8 - 1.25. Both formulations were well tolerated by volunteers., Conclusion: This study confirmed that sildenafil granules and sildenafil tablet are bioequivalent with regards to pharmacokinetics of sildenafil and N-desmethyl sildenafil.