None listed
Conditions
Interventions
Drug : Single oral administration of reference drug(VIVIANT TAB.20 mg) under fasting conditions and single oral dose of test drug(Vivantzheng 20 milligrams) under fasting conditions 14 days apart.
Sponsors
Huons
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy adult volunteers over the age of 19 at screening. 2)Subject who weight was = 55 kg and ideal body weight (IBW) was within ±20% - Ideal Body Weight (IBW, kg) = (Height(cm) - 100) × 0.9 3)Subject who don’t have congenital or chronic disease and any pathologic sign or symptom from medical check-up. 4)Subject who be within normal range by clinical laboratory results such as hematology test, blood chemistry test, urine test, etc. 5)Subject who be confirmed not to be pregnant through pregnancy test. 6)Subject who be informed of and completely understood this clinical trial and signed the written informed consent for voluntary participation.
Exclusion criteria
Exclusion criteria: 1)Subject who have a clinically significant past or present medical history of hepato-biliary, renal, gastrointestinal, respiratory, hematologic/neoplastic, endocrine (Especially patients with type 1 diabetes or diabetic ketoacidosis, diabetic pre-coma), urologic, psychiatric, musculoskeletal, immunologic, otorhinolaryngological, and cardiovascular diseases. 2)Subject with a history of gastrointestinal disease (e.g. Crone’s disease, ulceration, acute or chronic pancreatitis, etc) or surgery (except simple appendectomy or repair of a hernia), which can influence the absorption of the study drug. 3)Patient with prostatic hypertrophy or glaucoma. 4)Subject who laboratory findings under any of the followings. - AST, ALT > UNL(upper normal limit) x 2.0 - eGFR < 60 mL/min/1.73m2 from Modification of Diet in Renal Disease Study 5)Subject who systolic blood pressure (SBP) < 100 mmHg or > 140 mmHg, diastolic blood pressure (DBP) < 90 mmHg or < 60 mmHg or pulse rate (PR) = 100 /min in sitting position. 6)Subject who took barbiturates or an inducer or inhibitor of drug metabolite enzymes within 30 day before the first study drug administration. 7)Subject who took central nervous system depressants drugs or Anticholinergic drugs within 30 days before the first study drug administration and subject whose other conditions are judged by investigators as not appropriate for this clinical trial could not participate in this study. 8)Subject who have participated in bioequivalence studies or other clinical trials within 6 months of the first day of study drug administration. 9)Subject who donated whole blood within 2 months or blood components within 1 month before the first administration, or who received blood transfusion within 1 month before the first administration. 10)Subject who has a history or presence of regular consumption exceeding an average weekly intake of > 21 units of alcohol in recent 6 months prior to the Screening visit or unable to refrain from drinking during within 48 hours prior to the study drug administration and until last pharmacokinetic sampling.(250 ml of beer (5%)) = 10 g, soju (20%) 1 cup (50 ml) = 8 g, wine (12%) 1 cup (125 ml) = 12 g) 11)Smokers with an average daily smoking amount exceeding 10 cigarettes per day in recent 3 months prior to the Screening visit or unable to refrain until last pharmacokinetic sampling from 48 hours prior to administration of study drug. 12)lactating women. 13)Subejct who do not agree to use medically acceptable methods* of contraception from first study drug administration to 7 days after last administration of study drug. *Medically acceptable methods: combination of two or more of the following (intrauterine devices (IUD, IUS), vasectomy, fallopian tube ligation and blocking contraception (male condom, female) condom) or a combination of spermicide and two combinations of blocking contraception. 14)Uncontrolled genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 15)Subject with known hypersensitivity or history of allergy to the study drug containing Yellow No. 5 (Sunset Yellow FCF, Sunset Yellow FCF) 16)Those who are not willing or able to abide by the lifestyle guidelines described in study plan. 17)Subject who, in addition to the exclusion criteria above, has determined that the examiner is not suitable for participation in the bioequivalence test due to clinical laboratory test results or other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the Curve 0-t;Concentration max | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the Curve infinite;Terminal half-life;The time it takes a drug to reach the maximum concentration | — |
Countries
Korea, Republic of
Contacts
Public ContactKim hoon
Chungnam National University Hospital
Outcome results
None listed