MATERIALS AND METHODS: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study with a washout period of 7 days. All 28 adult male subjects were required to fast for at least 10 hours prior to drug administration and they were given access to water ad libitum during this period. Thirty minutes prior to dosing, all subjects were served with a standardized high-fat and high-calorie breakfast with a total calorie of 1000 kcal which was in accordance to the EMA Guideline on the Investigation of Bioequivalence. Subsequently, subjects were administered either the test or reference preparation with 240mL of plain water in the first trial period. During the second trial period, they received the alternate preparation. Plasma levels of glibenclamide and metformin were analysed separately using two different high performance liquid chromatography methods.
RESULTS: The 90% confidence interval (CI) for the ratio of the AUC0-t, AUC0-∞, and Cmax of the test preparation over those of the reference preparation were 0.9693-1.0739, 0.9598- 1.0561 and 0.9220 - 1.0642 respectively. Throughout the study period, no serious drug reaction was observed. However, a total of 26 adverse events (AE)/side effects were reported, including 24 that were definitely related to the study drugs, namely giddiness (n=17), while diarrheoa (n=3), headache (n=2) and excessive hunger (n=2) were less commonly reported by the subjects.
CONCLUSION: It can be concluded that the test preparation is bioequivalent to the reference preparation.
METHODS: The study was an interventional and crossover comparison. Twenty-one patients with TN were administered with LTG in comparison to CBZ. The clinical trials comprised two phases of 40 days each, with an intervening three-day washout period. The final titration in dose for LTG was 400 mg and 1,200 mg for CBZ. Efficacy of the medications involved was determined by visual analog scale (VAS) and verbal rating scale (VRS). Side effects were recorded through marking of the profiles of side effects encountered on administration of LTG and CBZ, together with baseline haematological, hepatic and renal investigations.
RESULTS: Both on VAS and VRS assessments, in terms of proportion of patients, CBZ benefitted 90.5% (19/21) of the patients with pain relief (p 0.05). Meanwhile, LTG inflicted 14% (3/21) of the patients with haematological, hepatic and renal derangements, as compared with 48% (10/21) on CBZ.
CONCLUSION: LTG is generally an effective and safe treatment for management of TN, compared to CBZ.
METHODS: We conducted an 8-week randomized crossover study on 16 Hemodialysis machines to compare CCS versus PPC. Performance is assessed by solute concentrations while safety is assessed by microbial count, endotoxin level and adverse event reporting.
RESULTS: Microbial counts and endotoxin levels were monitored on 48 occasions during the 8-week study for the CCS arm of the study. The levels were all below the action limit during the study. No patient reported any adverse events. Dialysate Sodium, Chloride and Bicarbonate concentrations were measured on a total of 128 occasions for each arm of the study. The relative deviations of Sodium, Chloride and Bicarbonate concentration were within ±5% of their nominal values for both. The 95% Confidence Intervals for the ratio of the mean solute concentrations on the CCS to PPC lie within the tolerance limit of ±5%.
CONCLUSION: Modern CCS is bacteriologically safe and its performance statistically equivalent to PPC.
METHODS: A 24 h plaque re-growth, double-blinded, randomized crossover trial was carried out. Participants (n = 14) randomly rinsed with test formulation, 0.12% chlorhexidine (control) and placebo mouthwashes for 24 h. A week before the trial, all participants received scaling, polishing and oral hygiene education. On the trial day, the participants received polishing at baseline and rinsed with 15 ml of randomly allocated mouthwash twice daily without oral hygiene measures. After 24 h, plaque index was scored and then the participants entered a 6-days washout period with regular oral hygiene measures. The same protocol was repeated for the next 2 mouthwashes.
RESULTS: The results were expressed as mean (±SD) plaque index. The test mouthwash (0.931 ± 0.372) significantly reduced plaque accumulation when compared with placebo (1.440 ± 0.498, p 0.0167).
CONCLUSIONS: The test mouthwash has an anti-plaque effect for a 24 h period. Longer-term clinical studies are highly encouraged to investigate its anti-plaque effect for longer periods.
TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov as NCT02624336 in December 3, 2015.
METHODS: Using a randomised double-blind crossover design, 21 (men = 6, women = 15) T2D subjects consumed test meals (3.65 MJ) consisting of a high fat muffin (containing 50 g test fats provided as PO, IPO or HOS) and a milkshake. Postprandial changes in gut hormones, glucose homeostasis, satiety, lipid and inflammatory parameters after meals were analysed. Some of the solid fractions of the IPO were removed and thus the fatty acid composition of the PO and IPO was not entirely equal (PO vs IPO: palmitate 39.8 vs 38.7; oleate 43.6 vs 45.1). PO, IPO and HOS contained 9.7, 38.9 and 0.2 g/100 g total fatty acids of palmitic acid at the sn-2 position, respectively. At 37 °C, IPO contained 4.2% SFC whereas PO and HOS were completely melted.
RESULTS: Our novel observation shows that the incremental area under curve (iAUC) 0-6 h of plasma GIP concentration was on average 16% lower following IPO meal compared with PO and HOS (P
METHODS: Eight cyclists exercised at three submaximal intensities before completing a TTE100% at sea-level (SEA) and at 1657 m of altitude (ALT), with pre-exercise consumption of 1000 mg of POMx or a placebo (PLAC) in a randomized, double-blind, crossover design. Data were analysed using a three way (treatment x altitude x intensity) or two-way (treatment x altitude) repeated measures ANOVA with a Fisher's LSD post-hoc analysis. Significance was set at p ≤ 0.05. The effect size of significant interactions was calculated using Cohen's d.
RESULTS: TTE100% performance was reduced in ALT but was not influenced by POMx (p > 0.05). Plasma NO3- were 10.3 μmol greater with POMx vs. PLAC (95% CI, 0.8, 19.7,F1,7 = 7.83, p 0.05). Submaximal VO2 values were not affected by POMx (p ≥ 0.05).
CONCLUSIONS: The restoration of SEA VO2 values at ALT is likely driven by the high polyphenol content of POMx, which is proposed to improve nitric oxide bioavailability. Despite an increase in VO2, no change in exercise performance occurred and therefore this study does not support the use of POMx as an ergogenic supplement.