Phase 1 Study of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers

NCT06318845 | Completed Phase 1

• 1 other identifier: 2302CS-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety and drug interaction of DHP2302R1 and DHP2302R2 when administered alone versus in combination in healthy South Korean adult participants.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• AUClast of DHP2302R1 and DHP2302R2

  Systemic exposure of DHP2302R1 and DHP2302R2

  At baseline (0 hours), administration day (Day 5 to Day 9) in each period

• Cmax of DHP2302R1 and DHP2302R2

  Plasma concentrations of DHP2302R1 and DHP2302R2

  At baseline (0 hours), administration day (Day 5 to Day 9) in each period

Secondary Outcomes (6)

• Tmax of DHP2302R1 and DHP2302R2

  At baseline (0 hours), administration day (Day 5 to Day 9) in each period

• AUC0-48 of DHP2302R1 and DHP2302R2

  At baseline (0 hours), administration day (Day 5 to Day 9) in each period

• AUCinf of DHP2302R1 and DHP2302R2

  At baseline (0 hours), administration day (Day 5 to Day 9) in each period

• t1/2 of DHP2302R1 and DHP2302R2

  At baseline (0 hours), administration day (Day 5 to Day 9) in each period

• CL/F of DHP2302R1 and DHP2302R2

  At baseline (0 hours), administration day (Day 5 to Day 9) in each period

Study Arms (6)

Sequence A

EXPERIMENTAL

DHP2302R1 75 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R2 50 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R1 75 mg+DHP2302R2 50 mg once daily for 7 days

Drug: DHP2302R1; Drug: DHP2302R2

Seqeunce B

EXPERIMENTAL

DHP2302R1 75 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R1 75 mg+DHP2302R2 50 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R2 50 mg once daily for 7 days

Drug: DHP2302R1; Drug: DHP2302R2

Sequence C

EXPERIMENTAL

DHP2302R2 50 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R1 75 mg+DHP2302R2 50 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R1 75 mg once daily for 7 days

Drug: DHP2302R1; Drug: DHP2302R2

Sequence D

EXPERIMENTAL

DHP2302R2 50 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R1 75 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R1 75 mg+DHP2302R2 50 mg once daily for 7 days

Drug: DHP2302R1; Drug: DHP2302R2

Seqeunce E

EXPERIMENTAL

DHP2302R1 75 mg+DHP2302R2 50 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R2 50 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R1 75 mg once daily for 7 days

Drug: DHP2302R1; Drug: DHP2302R2

Seqeunce F

EXPERIMENTAL

DHP2302R1 75 mg+DHP2302R2 50 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R1 75 mg once daily for 7 days, followed by 2 weeks of washout period; then DHP2302R2 50 mg once daily for 7 days

Drug: DHP2302R1; Drug: DHP2302R2

Interventions

DHP2302R1 DRUG

75 mg per dose, once daily

Seqeunce B; Seqeunce E; Seqeunce F; Sequence A; Sequence C; Sequence D

DHP2302R2 DRUG

50 mg per dose, once daily

Seqeunce B; Seqeunce E; Seqeunce F; Sequence A; Sequence C; Sequence D

Eligibility Criteria

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

You may qualify if:

• Healthy adult, age ≥ 19 years at the time of screening
• Body weight ≥ 50.0 kg, with body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2 at the time of screening
• A subject with no congenital, treatment-requiring chronic diseases, pathologic symptoms, or findings on internal medicine examination.
• A subject determined to be suitable for the study as a result of clinical laboratory tests, vital signs, medical examination (physical examination), 12-lead electrocardiogram, and other tests set according to the characteristics of the investigational drug.
• A subject voluntarily decided to participate and agreed in writing to comply with the subject compliance for the duration of the clinical trial.

You may not qualify if:

• A subject with a current clinically significant liver, kidney, nervous, psychiatric, respiratory, endocrine, hematologic, tumor, genitourinary, cardiovascular, digestive, musculoskeletal, etc. diseases or history
• Kidney disorders
• Liver disorders
• Those with bleeding disorders (peptic ulcer, intracranial hemorrhage, hemophilia, digestive tract bleeding, urinary tract bleeding, hemorrhage, vitreous hemorrhage, etc.)
• For women, pregnant women (Urine-HCG positive) or nursing mothers
• A subject hypersensitivity or history of clinically significant hypersensitivity to clopidogrel, tegoprazan, or any component of the investigational drug, aspirin, or benzimidazole
• A subject with a genetic condition such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• A subject with a history of gastrointestinal disease (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (but not simple appendectomy or hernia surgery) that may affect the absorption of the investigational drug.
• A subject with clinically significant findings on 12-lead electrocardiogram at screening, including the following findings
• QTc \> 450 ms in men and QTc \> 470 ms in women
• PR interval \> 200 ms
• QRS duration \> 120 ms
• A subject with the following findings in clinical laboratory tests at the time of screening
• AST, ALT, ALP, γ-GT, and Bilirubin total \> 2 times the upper limit of normal range in clinical laboratory tests for liver function evaluation
• Creatinine level in the blood exceeds the reference range or eGFR calculated by the CKD-EPI formula less than 60 mL/min/1.73 m2

Sponsors & Collaborators

• Daehwa Pharmaceutical Co., Ltd.: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 4, 2024
• Primary Completion: April 26, 2024
• Study Completion: May 7, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)