East West Medical Research Institute

To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus. This was a phase 3, multicenter, open-label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks. The primary endpoint was the proportion of participants in each treatment arm who manifested treatment-induced anti-insulin antibodies (AIA). Secondary endpoints included efficacy and safety metrics, changes in glycated haemoglobin levels, and a comparative assessment of adverse events. Results were analysed using an equivalence test comparing the limits of the 90% confidence interval (CI) for treatment-induced AIA development to the prespecified margins. The percentages of participants positive for treatment-induced glycated haemoglobin by week 26 were similar between the GL Glargine (19.2%) and Lantus® (21.3%) treatment groups, with a treatment difference of -2.1 percentage points and a 90% CI (-7.6%, 3.5%) (predefined similarity margins: -10.7%, 10.7%). The difference in glycated haemoglobin was -0.08% (90% CI, -0.23, 0.06). The overall percentage of participants with any treatment-emergent adverse events was similar between the GL Glargine (80.1%) and Lantus® (81.6%) treatment groups. GL Glargine was similar to Lantus® in terms of immunogenicity, efficacy,and safety, based on the current study.

Pregabalin binds to the α2δ auxiliary subunit of voltage-gated calcium channels, which are widely distributed throughout the central and peripheral nervous systems and modulate calcium-dependent neurotransmitter release. Pregabalin is indicated for the treatment of peripheral and central neuropathic pain, partial seizures with or without secondary generalization, and treatment of generalized anxiety disorder (GAD). The purpose of this study was to assess the bioequivalence of two different formulations of pregabalin 150-mg capsules in healthy Korean male subjects under fasting conditions. This bioequivalence study was based on an open-label, single-dose, randomized, 2-period, 2-sequence crossover design with a washout period of 7days. Blood samples for pharmacokinetic (PK) evaluation were collected up to 24hours postdose. Plasma concentrations of pregabalin were determined using a validated LC-MS/MS method. PK parameters were determined using noncompartmental analysis. Bioequivalence was assumed if the 90% confidence intervals (CIs) for the test/reference ratios of log-transformed C_max and AUC_last values met the bioequivalence criteria specified by Korean regulatory guidelines (90% CI 0.8-1.25). The extent of exposure in terms of AUC_last amounted to 26,018.3-3,580.8µg×h/L for the test formulation and 25,680.2±3,083.6µg×h/L for the reference formulation. C_max reached values of 4,782.7±1,124.2µg/L and 4,654.0±911.4µg/L for the test product and reference product, respectively. The geometric mean ratio and 90% CIs of the test product to the reference product were 1.0132 (0.9862-1.0351) for AUC_last and 1.0153 (0.9351-1.1044) for C_max, which were well within the range necessary to establish bioequivalence (90% CI 0.8-1.25). The bioequivalence between test and reference formulations under fasting conditions was confirmed both in terms of the rate and extent of absorption. .

Osteo-F, a new herbal formula, ameliorates osteoporosis by up-regulating Runx2 and Osterix.

Objectives : Warm needling is the method combining the effects of acupuncture and moxibustion. In modern clinics, warm needling is only affected by treatment time or frequency. We need to study the physical characteristics of warm needles currently used in clinics in order to develop more efficient and economical treatments. Methods : We collected various warm needle specimens and analyzed chemical constitutions, measured heat transfer velocity, micro Vicker`s hardness and specific resistance. We studied the relationship between heat transfer velocity and micro Vicker`s hardness as well as that between heat transfer velocity and specific resistance. Results : The heat transfer velocity of the Silver_HL was 3.3 mm/sec, of the Au alloy group was 1.3~2.6 mm/sec, and Silver_IN, Silver_ZK and SS groups was less than 0.3 mm/sec. We therefore concluded that the needle composed of Ag has the best heat transfer velocity. In the Micro Vicker`s hardness test, Vicker`s hardness of the Au alloy group was 159~170 Hv, of Silver_HL was 181 Hv, and of the Silver_IN, Silver_ZK, SS group was 450.8~519 Hv. In the Silver_IN, Silver_ZK and SS groups, hardness was inversely proportial to thermal conductivity. In the specific resistance test, the specific resistance of Silver_HL was the lowest, that of the Au alloy group was the second lowest, and that of the Silver_IN, Silver_ZK, SS groups were the highest. Conclusions : We concluded that the needle composed of Ag has the best heat transfer velocity, highest electric conductivity and thermal conductivity, therefore the needle composed of Ag is suitable for warm needling.

Warm-needling (also called thermo-acupuncture) is a combination of acupuncture and moxibustion. Due to the intense heat involved, there have been concerns over the biological safety of the acuneedles used in the treatment. This paper reports two phases of a safety test. For a preliminary test, we compared the temperature change patterns of stainless steel (SS304) needles and traditional gold alloy needles, which have been increasingly replaced by the former. To verify the effects of the presence of coating materials, the main test involved three different kinds of SS304: silicone-coated, salicylic acid-coated and non-coated needles. Each group of needles was tested for pH level, heavy metals and UV absorbance spectrum along with biological tests on the cytotoxicity and hemolysis of the needle. All the tests on the extractants from the needles were negative. In the biological tests, each test result showed a significant difference from the positive control samples, while no significant difference was observed compared with the negative control samples. In the hemolysis tests, all samples satisfied the Korean Government Standards. All the results suggest that SS304 needles are biologically safe to be used in warm-needling, though they can be improved to perform as well as the gold alloy needles in terms of temperature fluctuations.