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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single sequence, 3-period | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D930, D565 | Drug | Period 1: D565 administered 1 time for one day/ Period 2: D930 administered 3 time per day for 9 days/ Period 3: D565(1 time per day) with D930(3 time per day) administered for 9days |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau,ss of D930 | predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h | |
| Cmax,ss of D930 | predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of D565 | predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h | |
| Cmax of D565 | predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h | |
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Inclusion Criteria:
Exclusion Criteria:
1. 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
2. Those who meet the following criteria on ophthalmological examination or test
3. 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
4. Clinical laboratory test results showing the following values
5. 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
6. 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.)
7. Those who have a history of drug abuse within the first year of screening
8. 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
9. Those taking medication known to induce or inhibit drug metabolizing enzymes within 30 days prior to the first administration of clinical trial medication
10. 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)
11. 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
12. 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)
13. Those who are not willing or able to comply with the lifestyle guidelines described in this Protocol,
14. An average of 10 smokers per day over the past three months or who can not quit smoking 48 hours before the first dose
15. 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,
16. A person who is found to be unsuitable for clinical trial participation due to other reasons including clinical laboratory test results
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| Name | Affiliation | Role |
|---|---|---|
| Min Kyu Park, Ph.D | The Dong-A University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Seo-gu | Busan | 602-715 | South Korea |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Tmax of D565 |
| predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h |
| t1/2 of D565 | predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h |
| AUCinf of D565 | predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h |
| Ctrough, ss of D930 | predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h |
| Tmax,ss of D930 | predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h |
| t1/2 of D930 | predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h |
| AUCinf of D930 | predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h |