Healthy VolunteersPhase 1NCT06318845
Phase 1 Study of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers
A Phase 1 study testing DHP2302R1 and DHP2302R2 in people with Healthy Volunteers, run by Daehwa Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DHP2302R1 and DHP2302R2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2024to 7 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 30Show fewer
- 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
- CPK > 2.5 times the upper limit of the normal range in clinical laboratory tests
- A subject with a history of drug abuse or positive urine drug screen for drugs of abuse
- 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
- A subject administered drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month before the first dose.
- 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
- 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).
- 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.)
- 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.
- 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
- 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.
- 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
- 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.
- 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.
- 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)).
- A subject unsuitable for participation in the study by the investigator for any reason other than the above inclusion/exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Drug-drug Interaction of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers
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.
- Conditions
- Healthy Volunteers
- Being tested
- DHP2302R1, DHP2302R2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHP2302R1Drug
75 mg per dose, once daily
DHP2302R2Drug
50 mg per dose, once daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: DHP2302R1; Drug: DHP2302R2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of DHP2302R1 and DHP2302R2
Systemic exposure of DHP2302R1 and DHP2302R2
Measured: 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
Measured: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
Secondary outcomes (6)
Tmax of DHP2302R1 and DHP2302R2
Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2
Measured: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
AUC0-48 of DHP2302R1 and DHP2302R2
Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2
Measured: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
AUCinf of DHP2302R1 and DHP2302R2
Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2
Measured: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
t1/2 of DHP2302R1 and DHP2302R2
Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2
Measured: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
CL/F of DHP2302R1 and DHP2302R2
Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2
Measured: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
Vz/F of DHP2302R1 and DHP2302R2
Secondary pharmacokinetic parameters of DHP2302R1 and DHP2302R2
Measured: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start4 Mar 2024
- Primary completion26 Apr 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daehwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318845
- Sponsor's protocol ID
- 2302CS-1
- Status last verified
- Jul 2024
- First submitted
- 12 Mar 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Drug-drug Interaction of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06318845
- Acronym / sponsor ID
- 2302CS-1
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Daehwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: DHP2302R1, Drug: DHP2302R2DHP2302R1 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 |
| Seqeunce B | Experimental | Drug: DHP2302R1, Drug: DHP2302R2DHP2302R1 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 |
| Sequence C | Experimental | Drug: DHP2302R1, Drug: DHP2302R2DHP2302R2 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 |
| Sequence D | Experimental | Drug: DHP2302R1, Drug: DHP2302R2DHP2302R2 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 |
| Seqeunce E | Experimental | Drug: DHP2302R1, Drug: DHP2302R2DHP2302R1 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 |
| Seqeunce F | Experimental | Drug: DHP2302R1, Drug: DHP2302R2DHP2302R1 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (30 listed)
- A subject with a current clinically significant liver, kidney, nervous, psychiatric, respiratory, endocrine, hematologic, tumor, genitourinary, cardiovascular, digestive, musculoskeletal, etc. diseases or history
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHP2302R175 mg per dose, once daily | Drug | Seqeunce B, Seqeunce E, Seqeunce F, Sequence A, Sequence C, Sequence D |
| DHP2302R250 mg per dose, once daily | Drug | Seqeunce B, Seqeunce E, Seqeunce F, Sequence A, Sequence C, Sequence D |
Primary outcome
AUClast of DHP2302R1 and DHP2302R2
Time frame: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
Systemic exposure of DHP2302R1 and DHP2302R2
Cmax of DHP2302R1 and DHP2302R2
Time frame: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
Plasma concentrations of DHP2302R1 and DHP2302R2
6 secondary outcomes
Tmax of DHP2302R1 and DHP2302R2
Time frame: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
AUC0-48 of DHP2302R1 and DHP2302R2
Time frame: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
AUCinf of DHP2302R1 and DHP2302R2
Time frame: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
t1/2 of DHP2302R1 and DHP2302R2
Time frame: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
CL/F of DHP2302R1 and DHP2302R2
Time frame: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
Vz/F of DHP2302R1 and DHP2302R2
Time frame: At baseline (0 hours), administration day (Day 5 to Day 9) in each period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DHP2302R1 and DHP2302R2 in people with Healthy Volunteers, run by Daehwa Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUClast of DHP2302R1 and DHP2302R2 (time frame: At baseline (0 hours), administration day (Day 5 to Day 9) in each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.