Randomized, open-label, single-dose, three-treatment, three-period, six-sequence, cross-over design phase 1 clinical trial to compare the pharmacokinetics and safety/tolerability after oral administration of Mytonin Tab. 25mg and IY-HCR17 in healthy volunteers

Not Applicable

Completed

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0003368
• Lead Sponsor: Seoul National University Bundang Hospital

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: 36

Inclusion Criteria

1) 19~45 yrs old, healthy subjects at screening
2) Subjects who are confirmed as non-pregnant in female at screening
3) Body mass index(BMI) 18~30(BMI Calculation: weight(kg)/height(m2))
4) Those who signed and dated the Informed Consent Form(ICF) voluntarily after fully understanding the ICF <Appendix 3> of this clinical trial.
5) Subjects who are willing to follow all planned hospitalization and outpatient visits, administration, laboratory tests and subject compliances.
6) Those who are judged by Institution Principal Investigator(or delegated Sub-Investigator) to be suitable as subjects for results of the laboratory tests such as Hematology, Blood chemistry, Urinalysis etc.)

Exclusion Criteria

1) Subjects who have mechanic gastrointestinal tract or urinary tract, spastic gastrointestinal disorders, gastric ulcer, acute gastrointestinal tract inflammatory disease, peritonitis or history of peritonitis, bradycardia or atrioventricular conduction disturbance
2) Subjects who have taken drugs within a month prior to screening, which are inducing(ex: Barbiturate) or deducing drug metabolite enzymes
3) Subjects who have taken drugs within 10 days prior to screening, which could affect this trial.
4) Subjects who have participated in other clinical trials and taken drugs or have participated in bioequivalence trial and taken drugs within 3 months prior to the first administration of investigational product
5) Subjects who have given whole blood donation within 2 months or blood component donation within a month prior to the first scheduled administration of investigational product, or have received transfusion within a month prior to the first scheduled administration of investigational product
6) Subject who is unable to perform pharmacokinetic blood-gathering for trial and blood-gathering for safety assessment due to Hypersensitivity to venipuncture
7) A smoker of 10 cigarettes/day on average over the past 3 months or a person who cannot abstain from smoking during the period from 3 days prior to the scheduled first administration of investigational product to close-out visit
8) A habitual drinker (>21 units/week, 1 unit = 10 g of pure alcohol) within 4 weeks prior to screening or a person who cannot abstain from alcohol consumption during the clinical trial
9) Individual having gastrointestinal diseases that can affect the absorption of drugs (Crohn’s disease, ulcers, acute or chronic pancreatitis, etc.) or having a history of gastrointestinal surgery (however, simple appendectomy or hernia surgery are excluded).
10) Subjects who have clinical significant diseases of liver, kidney, nervous system, immune system, respiratory system, endocrine system, or hemato·oncology, cardiology, mental disorder(Mood disorder, obsessive-compulsive disorder etc.) or who has past history(in the case of the liver disease, including subjects who have hepatitis viruses)
11) Vagotonia patient, asthma patient, hyperthyroidism patient, coronary artery obstruct patient, vasomotor incomplete patient, myocardial infarction patient, Severe cardiac disease patient, epilepsy and Parkinson's disease patient, patient who are treated with cholinesterase inhibitor, not recovered patient after surgery of gastrointestinal tract anastomosis
12) Subject who had some lab data below.
After the break in the sitting position measured vital signs, systolic blood pressure < 90 mmHg or > 150 mmHg or diastolic blood pressure < 60 mmHg or > 95 mmHg
13)Clinical laboratory test at screening
? AST(SGOT), ALT(SGPT) > above (upper limit of normal reference range)x 1.5
? Serum creatinine > above upper limit of normal reference range
? QTc >450 msec or clinically significant abnormal rhythm in electrocardiography
14) Drug abuse history or positive finding in urine drug screening
15) Subjects who do not agree with personally using appropriate method of contraception during trial.
- (IUD (Intrauterine device), IUS (Intrauterine system), vasectomy, tubal ligation, barrier method(a male condom, a female condom, a cervical cap, contraceptive diaphragms, contraceptive sponge etc.)
16) Subjects who have unusual eating habit(ex: continu

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability assessment- Adverse events after administration of study drug, Concomitant medication monitroing, vital sign, electrocardiogram, laboratory test;Pharmacokinetics assessment- Primary end-point AUC, Cmax;Demographic assessment-Gender, age, height, weight and BMI of subjects participating in the clinical trial

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics assessment- Secondary end-point : AUCinf, Tmax, T1/2, CL/F, Vd/F