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Phase 1 study of azosemide (SK-110): single- and multiple-dose study
International Journal of Clinical Pharmacology, Therapy, and Toxicology
|January 1, 1983
Summary
SK-110, a potential diuretic, was tested in healthy volunteers. The drug increased urine output and electrolyte excretion with mild dehydration as the only side effect, showing a favorable safety profile.
Area of Science:
- Pharmacology
- Clinical Trials
- Nephrology
Background:
- Diuretics are essential in managing fluid balance and cardiovascular conditions.
- Understanding the pharmacokinetic and pharmacodynamic profile of new diuretic agents is crucial for therapeutic development.
Purpose of the Study:
- To evaluate the safety, tolerability, and pharmacokinetic profile of SK-110 in healthy volunteers.
- To assess the diuretic and electrolyte-modulating effects of single and multiple oral doses of SK-110.
Main Methods:
- Healthy volunteers received single and multiple oral doses of SK-110.
- Clinical observations, laboratory examinations, and urinary output/electrolyte excretion measurements were conducted.
- Plasma concentrations of SK-110 were monitored over time.
Main Results:
- SK-110 was well-tolerated, with dehydration being the primary observed side effect, attributed to its diuretic action.
- A dose-proportional increase in plasma concentration of SK-110 was noted, with peak levels at 3-4 hours post-administration.
- Significant increases in urinary output and electrolyte excretion were observed within one hour, with diuretic effects lasting approximately 9 hours.
Conclusions:
- SK-110 demonstrates a favorable safety and tolerability profile in healthy volunteers.
- SK-110 exhibits potent diuretic and electrolyte-excreting properties.
- The pharmacokinetic profile suggests predictable absorption and elimination, supporting further investigation of SK-110 as a therapeutic diuretic.