Evaluation of the safety and pharmacokinetics of FOM-D31 and desmopressin tablet

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0000821
• Lead Sponsor: Kuhnil Pharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Healthy adults between the ages of 20 and 55 years
2. Body weight more than 55 kg, and within 20% of ideal body weight (IBW)
IBW (kg)=[height(cm)-100]?0.9
3. Have not any congenital or chronic disease and medical symptoms
4. No clinically relevant abnormalities identified by laboratory test, including Hematology, Blood chemistry, Urinalysis
5. Agreement with written informed consent

Exclusion Criteria

1. Subjects who has clinically relevant current disease or history of liver-biliary teact, kidney, central (peripheral) nervous system, cardiovascular system, blood tumor, urinary system, mental disease, musculoskeletal system, immune system, otorhinolaryngologic system, endocrine system
2. Subjects who has a history of gastrointestinal disease that may affect the bioavailability of the study preparation
3. Subjects who are hypersensitive to desmopressin or other related compounds.
4. SBP =130 mmHg or = 85 mmHg, DBP = 90 mmHg or = 60 mmHg in the sitting position after a 3 minute rest
5. Serum sodium level <133 mEq/L
6. Creatinin clearance < 50 mL/min according to Cockcroft-Gault equation
7. Using diuretics
8. History of drug abuse or currently using an abusable medicine
9. Received OTC drugs or vitamins within a week, or ETC drugs or oriental medicine within 2 weeks before the first IP administration
10. Previously any IP administration in other trial within 60 days
11. Previously make whole blood donation within 2 months or component blood donation within a month or blood transfusion within a month before the first IP administration
12. Chronic alcohol consumption (21 units/week, 1 unit=10 g of pure alcohol) or disagreement to abstain from alcohol during study periods
13. Who have smoked >10 cigarettes per day for the past 3 months
14. Inappropriate subject for entry into this study in the judgement of the investigator
15. Pregnant or nursing female

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUCt and Cmax

Secondary Outcome Measures

Name	Time	Method
AUCinf, CL/F, t1/2ß, tmax and safety