The Pharmacokinetics of D565 and the Drug Effect of D565 on Pharmacokinetic Characteristics of D930

Chong Kun Dang

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: D930, D565

Study type

Interventional

Funder types

Industry

Identifiers

NCT03034486

171DDI16019

Details and patient eligibility

About

This study is a single sequence, 3-period, multiple-dose study to evaluate the pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of D930 in healthy male volunteers.

Full description

Subjects will receive D565 just one time on period 1 for evaluate the pharmacokinetics. And afterward, subjects will receive multiple dose of D930 for 9 days, and D565 with D930 for 9 days to evaluate the drug effect on period 2 and 3.

When period 1 finished, there are 3 days of washout period, but between period 2 and 3, there is no washout period.

Enrollment

15 patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male older than 19 years and younger than 55 years at the time of screening
BMI 18.0~30.0(kg/m2) and body weight more than 55kg
Subject who has no chronic disease within last 3 years, no symptoms or pathological findings
Suitable subject who is determined by laboratory tests that hematology test, blood chemistry, urinalysis test according to the characteristics of the drug and 12-lead ECG at the time of screening
Subject who fully understand the purpose and content of clinical trials, characteristic of the drug after in-depth explanation, decided to join the clinical trials by their will and signed inform consent
Subject who has will and ability to participate in clinical trials

Exclusion criteria

Subject who has a history of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, allergic or ophthalmic diseases (except for asymptomatic seasonal allergies not treated at the time of single administration) or who has a following history
Patients with liver failure or severe renal disease(CCr < 30ml/min) and cardiovascular patient (CCr is calculated by Cockroft and Gault formula)
Patients with acute occlusion angle glaucoma
Patients with a history of kidney stones
Patients with a history of chronic corneal injury and ophthalmic surgery
Patients with decreased endothelial cell count
Patients with renal tubular cells immature or with perchloric acidosis
Patients receiving MAO inhibitor
Patients taking antidepressants that affect noradrenaline delivery
Patients with depression, cerebral impairment or coronary artery disease, Raynode phenomenon, standing hypotension, and obstructive thromboangitis
Patients with bronchial asthma or history of asthma
Those who meet the following criteria on ophthalmological examination or test
A person with a history or suspected symptom of visual organs diseases including keratitis, iritis, uveitis, retinitis, dry eye syndrome, and strabismus.
Those who have had previous ophthalmic surgery or have undergone ophthalmic laser surgery within 6 months
Those whose corrected visual acuity measured at screening is 20/40 (acupuncture visual acuity chart 0.5) or less.
Those who have experienced side effects after wearing contact lenses, or who have worn contact lenses since the last month, who can not comply with the prohibition of wearing contact lenses during clinical trials
Others who have abnormal findings on ophthalmic examination
Patients with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of pharmaceuticals for clinical trials
Clinical laboratory test results showing the following values
ALT or AST> 2 times upper limit of normal range
eGFR <60 mL / min / 1.73m2 calculated by the Modification of Diet in Renal Disease (MDRD)
When the systolic blood pressure is less than 100 mmHg or more than 150 mmHg or diastolic blood pressure is less than 60 mmHg or not less than 100 mmHg
Those who have received medication within 3 months prior to the first administration of the clinical trial drug by participating in other clinical trials or bioequivalence studies (However, the ending date of participation in the examination shall be the last day of medication.)
Those who have a history of drug abuse within the first year of screening
Persons who have been drinking continuously (21 units / week, 1 unit = 10 g of pure alcohol) within 6 months of the first dose or who can not abstain during the trial Example> Beer 5 ° 1 cup (250 ml) = 10 g, Soju 20 ° 1 cup (50 ml) = 8 g, Wine 12 ° 1 cup (125 ml) = 12 g
Those taking medication known to induce or inhibit drug metabolizing enzymes within 30 days prior to the first administration of clinical trial medication
A person taking any prescribed medicinal product or herbal medicine within 2 weeks of the first day of administration or taking or applying any OTC drug or vitamin preparation including artificial tears within 1 week (However, depending on the testee's judgment, other conditions may be appropriate to participate in the clinical trial)
Those who have received a whole blood donation within 2 months before the first administration of the drug for clinical trial, or have received a blood donation and blood transfusion within 1 month
Persons with hypersensitivity or clinically significant hypersensitivity reactions to medicinal products for use in clinical trials or drugs containing the same class of ingredients (eg. latanoprost, benzalkonium chloride)
Those who are not willing or able to comply with the lifestyle guidelines described in this Protocol,
An average of 10 smokers per day over the past three months or who can not quit smoking 48 hours before the first dose
Those who are planning to become pregnant during the trial period or who are not planning to use a reliable contraceptive method (Eg, use of contraceptives and transplants or intrauterine devices, infertility procedures (vasectomy, tubal ligation, etc.), blockage (condoms and spermicide), vaginal septa, vaginal sponges,
A person who is found to be unsuitable for clinical trial participation due to other reasons including clinical laboratory test results