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CompletedNCT06318845Updated Jul 25, 2024

Phase 1 Study of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers

A Phase 1 interventional study of DHP2302R1 and DHP2302R2 in Healthy Volunteers, sponsored by Daehwa Pharmaceutical Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by Daehwa Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a phase 1 open-label, multiple doses, 6-sequence, 3-period, and crossover study to evaluate the safety and pharmacokinetic drug interaction following 7 days of DHP2302R1 75 mg and DHP2302R2 50 mg in healthy South Korean adult participants.

A total of 42 participants, 7 per 6 groups, will enroll in the study. The participants will take 7 days of DHP2302R1 75 mg, DHP2302R1 50 mg alone or in combination, and 2 weeks of washout period at each period.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Daehwa Pharmaceutical Co., Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult, age ≥ 19 years at the time of screening
  2. Body weight ≥ 50.0 kg, with body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2 at the time of screening
  3. A subject with no congenital, treatment-requiring chronic diseases, pathologic symptoms, or findings on internal medicine examination.
  4. 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.
  5. A subject voluntarily decided to participate and agreed in writing to comply with the subject compliance for the duration of the clinical trial.

Exclusion criteria

Exclusion Criteria:

  1. A subject with a current clinically significant liver, kidney, nervous, psychiatric, respiratory, endocrine, hematologic, tumor, genitourinary, cardiovascular, digestive, musculoskeletal, etc. diseases or history

    1. Kidney disorders
    2. Liver disorders
    3. Those with bleeding disorders (peptic ulcer, intracranial hemorrhage, hemophilia, digestive tract bleeding, urinary tract bleeding, hemorrhage, vitreous hemorrhage, etc.)
  2. For women, pregnant women (Urine-HCG positive) or nursing mothers
  3. A subject hypersensitivity or history of clinically significant hypersensitivity to clopidogrel, tegoprazan, or any component of the investigational drug, aspirin, or benzimidazole
  4. A subject with a genetic condition such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  5. 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.
  6. A subject with clinically significant findings on 12-lead electrocardiogram at screening, including the following findings

    1. QTc > 450 ms in men and QTc > 470 ms in women
    2. PR interval > 200 ms
    3. QRS duration > 120 ms
  7. A subject with the following findings in clinical laboratory tests at the time of screening

    1. AST, ALT, ALP, γ-GT, and Bilirubin total > 2 times the upper limit of normal range in clinical laboratory tests for liver function evaluation
    2. 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
    3. CPK > 2.5 times the upper limit of the normal range in clinical laboratory tests
  8. A subject with a history of drug abuse or positive urine drug screen for drugs of abuse
  9. A subject with systolic blood pressure ≥ 150 mm Hg or ≤ 90 mm Hg or diastolic blood pressure ≥ 100 mm Hg or ≤ 60 mm Hg and pulse ≤ 40 bpm or ≥ 100 bpm, which was measured in the sitting position after at least 3 minutes of rest, at the time of screening
  10. A subject administered drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month before the first dose.
  11. A subject with an unusual diet that may affect the absorption, distribution, metabolism, and excretion of the investigational drug or consume foods that may affect drug metabolism
  12. A subject who received any specialty or herbal medications that may affect the properties of the investigational product, including cyclosporine, CYP2C19 inhibitors, atazanavir, nelfinavir, or rilpivirine-containing preparations within 2 weeks before the first dose, or any over-the-counter (OTC) or vitamin preparations within 10 days (however, if the medication does not affect the pharmacokinetic properties of the investigational product, the subject may participate in the study at the discretion of the investigator).
  13. A subject who participated in and received treatment in another clinical trial within 6 months before the first dose (however, the termination criteria for participation in another clinical trial shall be the day following the last dose.)
  14. A subject who donated whole blood within 2 months before the first dose, or component blood within 1 month, or received a blood transfusion within 1 month, or needed to must donate blood from written informed consent to the time of PSV.
  15. A subject with consistent alcohol consumption (> 21 units/week, 1 unit=10 g=12.5 mL of pure alcohol) within 6 months before the first dose or unavailable to stop alcohol consumption from written informed consent to the time of PSV
  16. A subject who smokes with an average daily cigarette consumption greater than 10 cigarettes within 3 months before the first dose and who is unable to quit smoking from 24 hours before the first dose at each time point until the time of the last blood draw.
  17. A subject with consumption of or inability to abstain from grapefruit (grapefruit)-containing foods from 48 hours before the first dose until the time of PSV
  18. A subject with consumption of or inability to abstain from caffeine-containing foods (coffee, green tea, black tea, carbonated beverages, coffee milk, tonic drinks, etc.
  19. A subject who engaged in vigorous exercise that exceeds the level of their daily routine from 48 hours before the first dose to the time of PSV, or unavailable to abstain from vigorous exercise.
  20. A subject or his/her spouse or partner who is planning to become pregnant from written informed consent until 2 weeks after the last dose of investigational product, or is not using a reliable method of contraception (e.g., contraceptive administration and implantation or intrauterine device, sterilization (vasectomy, tubal ligation, etc.), barrier method (combination of spermicide with condoms, contraceptive vaginal septum, vaginal sponge, or neck cap)).
  21. A subject unsuitable for participation in the study by the investigator for any reason other than the above inclusion/exclusion criteria
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Sequence A

    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

  • Experimental
    Seqeunce B

    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

  • Experimental
    Sequence C

    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

  • Experimental
    Sequence D

    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

  • Experimental
    Seqeunce E

    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

  • Experimental
    Seqeunce F

    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

  • DrugDHP2302R1

    75 mg per dose, once daily

  • DrugDHP2302R2

    50 mg per dose, once daily

06

What researchers measure

Primary outcomes

  1. AUClast of DHP2302R1 and DHP2302R2

    Systemic exposure of DHP2302R1 and DHP2302R2

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

  2. Cmax of DHP2302R1 and DHP2302R2

    Plasma concentrations of DHP2302R1 and DHP2302R2

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

Secondary outcomes

  1. Tmax of DHP2302R1 and DHP2302R2

    Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2

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

  2. AUC0-48 of DHP2302R1 and DHP2302R2

    Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2

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

  3. AUCinf of DHP2302R1 and DHP2302R2

    Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2

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

  4. t1/2 of DHP2302R1 and DHP2302R2

    Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2

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

  5. CL/F of DHP2302R1 and DHP2302R2

    Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2

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

  6. Vz/F of DHP2302R1 and DHP2302R2

    Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2

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

07

Study locations

1 site
  • H Plus Yangji Hospital
    Seoul, Gwanak-gu 08779, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06318845
Lead sponsor
Daehwa Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 19, 2024
Start date
Mar 4, 2024
Primary completion
Apr 26, 2024
Completion
May 7, 2024
Last update
Jul 25, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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