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
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.
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.
Daehwa Pharmaceutical Co., Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
A subject with a current clinically significant liver, kidney, nervous, psychiatric, respiratory, endocrine, hematologic, tumor, genitourinary, cardiovascular, digestive, musculoskeletal, etc. diseases or history
A subject with clinically significant findings on 12-lead electrocardiogram at screening, including the following findings
A subject with the following findings in clinical laboratory tests at the time of screening
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
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
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
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
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
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
75 mg per dose, once daily
50 mg per dose, once daily
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
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
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
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
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
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
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
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
Plan to share: No
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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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Daehwa Pharmaceutical Co., Ltd.