A Crossover Study of DWJ1525 to Evaluate the Safety and Pharmacokinetic Properties in Healthy Volunteers

NCT05192395 | Completed Phase 1

• 1 other identifier: DW_DWJ1525101
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Four-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of DWJ1525 and the Co-administration of DWP16001 and DWC202101 for Healthy Subjects in Fed and Fasted State

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUClast

  AUClast of plasma DWP16001 and DWC202101

  At pre-dose (0) and 0.25 to 72 hours post dose

• Cmax

  Cmax of plasma DWP16001 and DWC202101

  At pre-dose (0) and 0.25 to 72 hours post dose

Study Arms (2)

Group A

EXPERIMENTAL

fed state: period 1) DWJ15251, period 2) DWP16001 and DWC2021011 fased state: period 3) DWJ15251, period 4) DWP16001 and DWC2021011

Drug: DWJ1525; Drug: DWP16001; Drug: DWC202101

Group B

EXPERIMENTAL

fed state: period 1) DWP16001 and DWC2021011, period 2) DWJ15251 fased state: period 3) DWP16001 and DWC2021011, period 4) DWJ15251

Drug: DWJ1525; Drug: DWP16001; Drug: DWC202101

Interventions

DWJ1525 DRUG

DWJ1525

Group A; Group B

DWP16001 DRUG

DWP16001

Group A; Group B

DWC202101 DRUG

DWC202101

Group A; Group B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Before participating in the clinical trial, a person who fully explained the purpose, content, and characteristics of the clinical trial drug and signed a written consent form approved by the IRB of Bundang Cha Hospital to participate in this study according to his free will.
• Healthy adults aged 19 or older at the time of screening.
• Those who weigh more than 50 kg in men, weigh more than 45 kg in women, and have a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2 or less in women.
• Body mass index (BMI) = Weight (kg) / \[Height (m)\] 2.

You may not qualify if:

• A person with a clinically significant history in liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, blood and tumor system, cardiovascular system (including orthostatic hypotension), etc.
• A history of gastrointestinal diseases (e.g., esophageal diseases such as Crohn's disease, esophageal achalasia, or esophageal stenosis) or surgery (except appendectomy, hernia, endoscopic polyp surgery, hemorrhoids, hemorrhoids, hemorrhoids, and healing surgery).
• Those who are hypersensitive to other drugs (aspirin, antibiotics, etc.) or have a history of clinically significant hypersensitivity reactions, including clinical drug ingredients (Enavogliflozin, Metformin) and homogeneous (SGLT2 inhibitors)
• A person who shows the following results in the inspection items conducted during screening.
• Blood ALT, AST, Total bilirubin \> twice the upper limit of the normal range
• The glomerular filtration rate (e-GFR) \<90 mL/min/1.73 m2 (using the CKD-EPI method)
• If the blood glucose level is greater than 125 mg/dL or less than 60 mg/dL,
• After more than 3 minutes of rest, systolic blood pressure \> 150 mmHg or \<90 mmHg, or diastolic blood pressure \> 100 mmHg or \<50 mmHg in vital signs measured at the seat.
• A person whose abnormal results were judged to be clinically significant in screening test items (examination, vital signs, electrocardiogram, physical examination, blood, urinary examination, etc.) other than those mentioned in paragraph 4).
• Drugs that do not affect the safety and research results of the subject may be available within 14 days of the first administration of clinical trial drugs (including herbal medicines), general medicines (including vitamins), and health functional foods.)
• Those who took other clinical trial drugs within 180 days before the first scheduled date of administration of clinical trial drugs (however, the criteria for termination of participation in previous clinical trials are calculated as one day based on the last administration date.)
• A person who has continuously consumed more than 21 units/week (1 unit = 10g = 12.5 mL) within 6 months of screening or cannot abstain from drinking alcohol from 3 days before the first administration of clinical trial drugs to the last visit.
• ☞ Alcohol amount (g) = Consumption (mL) x frequency (%) x 0.8
• Those who smoke more than 10 cigarettes a day within 6 months of screening and who cannot quit smoking excessively from 3 days before the first clinical trial drug administration to the last visit or quit smoking from the date of hospitalization to the last blood collection.
• A person who donated whole blood within 8 weeks before the first scheduled date of administration of clinical trial drugs, or who donated whole blood within 4 weeks (plasma, platelet), or did not agree to prohibit blood donation until 30 days after the last administration date.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

CHA unuversity bundang medical center

Seongnam, South Korea

Location

MeSH Terms

Interventions

Enavogliflozin

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: January 5, 2022
• First Posted: January 14, 2022
• Study Start: April 15, 2022
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: July 11, 2022

Record last verified: 2021-11

Locations

KR (1)