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To obtain a balanced design, 16 subjects would have to be randomized. However, due to the incomplete block design with four periods for six treatments, a loss of efficiency of one-third was assumed. The study products were prepared and blinded on site by authorized unblinded study staff according to the randomization plan.

Subjects as well as the investigator were blinded to the dosage of study products and the lactulose formulation. Lactulose and glucose were dissolved in 250 mL of still water and were provided as a single oral dose under the supervision of the study staff. The single dose had to be ingested Testosterone Enanthate (Delatestryl)- FDA 5 min. Glucose was determined photometrically using a european economic review glucose dehydrogenase method.

Blood glucose concentrations were assessed over a period of 180 min at defined time points (0, 15, 30, 45, 60, 90, 120, 150, and 180 min post-dose). Data were transferred on a paper case report form to M. In particular, if CIs did not include the threshold of clinical relevance, it could be concluded that lactulose has no clinically relevant dui charges on blood glucose levels.

GI tolerability was assessed at each study visit Testosterone Enanthate (Delatestryl)- FDA the initial 180-min period and 24 h post dose using a 4-point Likert scale (none, mild, moderate or severe) to describe symptoms.

The number of bowel movements was counted at each study visit until 24 h post dose for the different treatment groups.

Adverse events (AEs) were recorded in diaries over the entire study period after written informed consent was obtained. AEs were coded according to the Testosterone Enanthate (Delatestryl)- FDA Medical Dictionary for Regulatory Activities (version 22. The Common Terminology Criteria for Adverse Events (version 5.

At each study visit, AEs were reviewed by the investigator and recorded in the case report form. No further covariates were considered.

Secondary endpoints were evaluated analogously to the primary endpoint. Data are presented for Testosterone Enanthate (Delatestryl)- FDA intention-to-treat population, which was identical to the per-protocol population in this study. Exploration of possible carryover effects was not obligatory due to the 7-d (allowed range 4 to 14 d) washout period.

A total of 32 subjects were screened, and 24 subjects were enrolled from November 2018 to March 2019. Demographic and baseline data of randomized subjects are summarized in Table 1. Overall, 16 subjects (66. The mean baseline values of fasting blood glucose ranged from 6. Only two patients had three to five bowel movements with discomfort per Testosterone Enanthate (Delatestryl)- FDA. Only two subjects used laxatives to encourage defecation before randomization.

However, these subjects abstained from using laxatives two days before and up to 24 h after the respective study visits. This slight imbalance did not constitute a protocol deviation. All 24 subjects were treated according to the randomization Testosterone Enanthate (Delatestryl)- FDA and successfully completed the study without any major protocol deviations.

This implies a net decrease in blood glucose concentration over time after lactulose intake compared to the respective baseline blood glucose level. Mean blood glucose concentration-time curves after intake of 20 g (Table 2) or 30 g (Table 3) crystal lactulose did not differ from the mean blood glucose concentration-time curve after intake Testosterone Enanthate (Delatestryl)- FDA water (Figure 2).

The mean blood glucose concentration-time curve for 20 g liquid lactulose was also comparable to that of water (Table 4). The maximum blood glucose concentrations appeared slightly higher after intake of the 30 g liquid lactulose compared to water, showing mean maximum increases of 1. Thus, the mean maximum increase after 30 g Testosterone Enanthate (Delatestryl)- FDA lactulose was 0. The median (range) Tmax was 30 min (0 to 60 min) after Testosterone Enanthate (Delatestryl)- FDA g liquid lactulose intake and 22.

A glucose dose of 30 g was expected to induce higher blood glucose concentrations than 30 g of lactulose. Indeed, significant differences (P 6).



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