Niflec Mechanism of Action

Pharmacology: Intestinal Lavage Effect: As a result of repeated oral administration of Niflec, it was shown that the intestinal content significantly decreased through watery stool excretion (in nonfasted, fasted rats and nonfasted rats which had undergone cecectomy) enabling the identification of a definite intestinal lavage effect. Likewise, in (16-hr fasted) dogs, repeated oral administration caused excretion liquid to become clear, also enabling the identification of a definite intestinal lavage effect.
Effects on Electrolyte Balance: Niflec does not practically alter serum Na⁺, Cl^- and blood pH in (16-hr fasted) dogs and (24-hr fasted) rats, hence do not significantly disturb serum electrolyte balance. Moreover, changes in urine volume and urinary electrolyte in (24-hr fasted) rats were found to be smaller than those in saline solution and balanced electrolyte solution (BES).
Pharmacokinetics: As a result of administering 1, 2, 3 and 5 L of the solution to healthy adult male volunteers, and 4 L to 6 healthy male volunteers, it was found that no major changes which could cause clinical problems to serum electrolyte, urine volume and electrolyte in the urine were identified in all dosing groups. It was also found that Niflec was discharged from the body with stool.
Clinical Results: At the Time of Application for Approval: Comparative clinical and general clinical studies in terms of its use as pre-treatment for colonoscopy and large bowel operation were carried out. Studies were targeted at a total of 1072 trial subjects at 120 trial sites throughout the country. The profile outcome given in Table 1 shows high levels of efficacy. (See Table 1.)

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At the Time of Filing an Application for Additional Use: Comparative clinical study between administration on the day prior to examination and administration on the day of examination in pre-treatment for colonoscopy was carried out. It was targeted at a total of 153 subjects at 21 trial sites throughout the country. The profile of the outcome given in Table 2 shows that the efficacy of administration on the day before examination is comparable to that of administration on the day of examination. (See Table 2.)

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