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

Diabetes type2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05928637
• Other study ID #: A125_03DDI2228
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2023
• Est. completion date: September 5, 2023

Study information

• Verified date: June 2023
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical trial to compare the pharmacokinetic characteristics and safety among D745, D759, and D150 in healthy subjects

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 5, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy adult aged between 19 to 50 at screening

2. Weight = 55kg(man) or 50kg(woman) with ideal body weight ±20%

3. Those who don't have clinically significant sign of diseases including history of 5 years.

4. Those who have been confirmed to be appropriate throughout screening health examination.

5. 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:

1. 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.

2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption.

3. Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin.

4. History of drug abuse.

5. 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

6. Under 5 min resting condition, systolic blood pressure =150 mmHg or or <90 mmHg, diastolic blood pressure =100 mmHg or <50 mmHg.

7. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

8. Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration.

9. Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs

10. 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

11. 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

12. Those who have used ETC, herbal medicinal preparations, OTC, vitamins 10 days before the first dosing date.

13. 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

14. Those who can't resist caffeine, drinking and smoking from 9am of administration day till discharge date.

15. 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

16. Woman who are pregnant or breastfeeding

17. Those who are deemed insufficient to participate in clinical study by investigators

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes type2

Intervention

Drug:
• D745, D759, D150
QD, PO for 5 days

Locations

Country	Name	City	State
Korea, Republic of	Catholic Hospital, Seoul	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt	Area under the concentration-time curve time zero to time	[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
Primary	Cmax	Maximum plasma concentration of the drug	[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