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

NCT05928637 | Completed Phase 1

• 1 other identifier: A125_03DDI2228
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes type2

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (6)

Sequence 1

EXPERIMENTAL

* 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.

Drug: D745, D759, D150

Sequence 2

EXPERIMENTAL

* 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.

Drug: D745, D759, D150

Sequence 3

EXPERIMENTAL

* 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.

Drug: D745, D759, D150

Sequence 4

EXPERIMENTAL

* 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.

Drug: D745, D759, D150

Sequence 5

EXPERIMENTAL

* 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.

Drug: D745, D759, D150

Sequence 6

EXPERIMENTAL

* 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.

Drug: D745, D759, D150

Interventions

D745, D759, D150 DRUG

QD, PO for 5 days

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Catholic Hospital, Seoul

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 3, 2023
• Study Start: July 10, 2023
• Primary Completion: August 29, 2023
• Study Completion: September 5, 2023
• Last Updated: March 12, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)