Investigation the introduction possibility on human experimental program with diuretics into the practical subject of pharmacology

Not Applicable

• Conditions: Japanese healthy adults

• Registration Number: JPRN-UMIN000017432
• Lead Sponsor: Showa University School of Medicine Department of Clinical Pharmacology

Brief Summary

Safety All six subjects completed a trial. After Furosemide administration, hypotensive adverse event caused by excessive urination was observed in a female subject. No adverse event and no large change of the vital signs were observed in the other study drug administration in the female subject and the other study subjects. In addition, any safety parameters in blood and urine were not deviated from those reference range. The effectiveness The total urine volume after the study drug administration were Furosemide 1,903mL, Spironolactone 1,230mL, Tolvaptan 2,021mL, Placebo 963mL. The urine volume in all diuretics were significantly different compared to placebo. In addition, the urine collection period which showed the largest urine volume was matched with the tmax of each diuretics. And the duration of urine volume increase was also expressed the characteristic for the elimination half-life of the each administered diuretics. From the change of the total amount of electrolyte excretion, the distinction of Furosemide seemed to be possibility, but additional consideration would be necessary for clearly distinction of other diuretics.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-01
• Study Completion: 2015-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

1) Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs (including health supplements). 2) Any history for drug allergy 3) Subjects who are taking in too much alcohol 4) Subjects within three months after the participation to other clinical trials 5) Subjects who are inadequate for enrollment judged by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison the diuretic effects in study drugs evaluated by urine volume, urine specific gravity and excretion volume of electrolytes in urine

Secondary Outcome Measures

Name	Time	Method
Safety assessment (biomarkers of renal injury, vital measurement, serum electrolytes, excretion and adverse event)