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A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of D745, D759, and D150

Primary Purpose

Diabetes type2

Status
Not yet recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
D745, D759, D150
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes type2

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adult aged between 19 to 50 at screening Weight ≥ 55kg(man) or 50kg(woman) with ideal body weight ±20% Those who don't have clinically significant sign of diseases including history of 5 years. Those who have been confirmed to be appropriate throughout screening health examination. Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haemato-oncology disorder, Cardiovascular disorder or Psychical disorder. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption. Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin. History of drug abuse. Following results in clinical examination Na < 135 mEq/L K < 3.4 mEq/L Ca > 10.5 mg/dL AST or ALT > 1.25 times more than normal range Total bilirubin > 1.5 times more than normal range Total cholesterol > 1.5 times more than normal range CKD-EPI < 60 mL/min/1.73 m2 HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin test = positive Under 5 min resting condition, systolic blood pressure ≥150 mmHg or or <90 mmHg, diastolic blood pressure ≥100 mmHg or <50 mmHg. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration. Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days or received blood transfusion in 30 days Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, or who have used drugs that may interfere with this study within 30 days before the first dosing day Those who have used ETC, herbal medicinal preparations, OTC, vitamins 10 days before the first dosing date. Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who can't resist caffeine, drinking and smoking from 9am of administration day till discharge date. Those who agree to contraception from the date of consent form was written till 2 weeks after the last dosing day and decide not to provide sperm during the participation of clinical trial Woman who are pregnant or breastfeeding Those who are deemed insufficient to participate in clinical study by investigators

Sites / Locations

  • Catholic Hospital, Seoul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Arm Description

Period 1: oral dose of D745 1 tablet. Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Period 3: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150.

Period 1: oral dose of D745 1 tablet. Period 2: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Period 3: multiple oral dose of 1 tablet of D759 and 2 tablets of D150.

Period 1: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Period 2: oral dose of D745 1 tablet. Period 3: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150.

Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Period 3: oral dose of D745 1 tablet.

Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Period 2: oral dose of D745 1 tablet. Period 3: multiple oral dose of 1 tablet of D759 and 2 tablets of D150.

Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Period 3: oral dose of D745 1 tablet.

Outcomes

Primary Outcome Measures

AUCt
Area under the concentration-time curve time zero to time
Cmax
Maximum plasma concentration of the drug

Secondary Outcome Measures

Full Information

First Posted
June 26, 2023
Last Updated
June 26, 2023
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05928637
Brief Title
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of D745, D759, and D150
Official Title
An Open-label, Randomized, Multiple-dose, Three-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Among D745, D759, and D150 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 10, 2023 (Anticipated)
Primary Completion Date
August 29, 2023 (Anticipated)
Study Completion Date
September 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A clinical trial to compare the pharmacokinetic characteristics and safety among D745, D759, and D150 in healthy subjects
Detailed Description
An open-label, randomized, multiple-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety among D745, D759, and D150 in healthy subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes type2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1: oral dose of D745 1 tablet. Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Period 3: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150.
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: oral dose of D745 1 tablet. Period 2: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Period 3: multiple oral dose of 1 tablet of D759 and 2 tablets of D150.
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Period 1: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Period 2: oral dose of D745 1 tablet. Period 3: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150.
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Period 3: oral dose of D745 1 tablet.
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Period 2: oral dose of D745 1 tablet. Period 3: multiple oral dose of 1 tablet of D759 and 2 tablets of D150.
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Period 3: oral dose of D745 1 tablet.
Intervention Type
Drug
Intervention Name(s)
D745, D759, D150
Intervention Description
QD, PO for 5 days
Primary Outcome Measure Information:
Title
AUCt
Description
Area under the concentration-time curve time zero to time
Time Frame
[0d, 12d, 24d] pre-dose, [2d, 14d, 26d] pre-dose, [3d, 15d, 27d] pre-dose, [4d, 16d, 28d] pre-dose, and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12h, [5d, 17d, 29d] 24h
Title
Cmax
Description
Maximum plasma concentration of the drug
Time Frame
[0d, 12d, 24d] pre-dose, [2d, 14d, 26d] pre-dose, [3d, 15d, 27d] pre-dose, [4d, 16d, 28d] pre-dose, and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12h, [5d, 17d, 29d] 24h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult aged between 19 to 50 at screening Weight ≥ 55kg(man) or 50kg(woman) with ideal body weight ±20% Those who don't have clinically significant sign of diseases including history of 5 years. Those who have been confirmed to be appropriate throughout screening health examination. Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haemato-oncology disorder, Cardiovascular disorder or Psychical disorder. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption. Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin. History of drug abuse. Following results in clinical examination Na < 135 mEq/L K < 3.4 mEq/L Ca > 10.5 mg/dL AST or ALT > 1.25 times more than normal range Total bilirubin > 1.5 times more than normal range Total cholesterol > 1.5 times more than normal range CKD-EPI < 60 mL/min/1.73 m2 HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin test = positive Under 5 min resting condition, systolic blood pressure ≥150 mmHg or or <90 mmHg, diastolic blood pressure ≥100 mmHg or <50 mmHg. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration. Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days or received blood transfusion in 30 days Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, or who have used drugs that may interfere with this study within 30 days before the first dosing day Those who have used ETC, herbal medicinal preparations, OTC, vitamins 10 days before the first dosing date. Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who can't resist caffeine, drinking and smoking from 9am of administration day till discharge date. Those who agree to contraception from the date of consent form was written till 2 weeks after the last dosing day and decide not to provide sperm during the participation of clinical trial Woman who are pregnant or breastfeeding Those who are deemed insufficient to participate in clinical study by investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Pil Han, M.D.
Phone
+82-02-3147-8356
Email
shan@catholic.ac.kr
Facility Information:
Facility Name
Catholic Hospital, Seoul
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Pil Han, M.D.
Phone
+82-02-3147-8356
Email
shan@catholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of D745, D759, and D150

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