A Phase 1 interventional study of DHP2306R1 and DHP2306R2 in Musculoskeletal Pain, sponsored by Daehwa Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. 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 Treatment
This phase 1 study is to evaluate the safety and pharmacokinetic drug interactions of DHP2306R1 and DHP2306R2 when administered alone and in combination in healthy conditions.
Participants will be taken DHP2306R1 and DHP2306R2 alone or combination for 3 period, randomized in six-sequence.
493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 54 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Daehwa Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history. Those who have
① Renal impairment
② Liver disorder
At the time of screening, those with clinically significant findings including the following findings on 12-lead electrocardiography
At the time of screening, a person who shows the following results in clinical laboratory tests
DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period; then DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period; then DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day
Drug: DHP2306R1 · Drug: DHP2306R2
DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period; then DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day, followed by 1 week of wash out period; then DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day
Drug: DHP2306R1 · Drug: DHP2306R2
DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period; then DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period; then DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day
Drug: DHP2306R1 · Drug: DHP2306R2
DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period; then DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day; then DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period
Drug: DHP2306R1 · Drug: DHP2306R2
DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day; then DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period; then DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period
Drug: DHP2306R1 · Drug: DHP2306R2
DHP2306R1 100mg+ DHP2306R2 75mg twice a day for 4ayds and DHP2306R1 100mg+ DHP2306R2 75mg once for a day; then DHP2306R2 75mg twice a day for 4days, and DHP2306R2 75mg once for a day, followed by 1 week of wash out period ; then DHP2306R1 100mg twice a day for 4 days, and DHP2306R1 100mg once for a day, followed by 1week of wash out period
Drug: DHP2306R1 · Drug: DHP2306R2
100mg per capsule, BID
75mg per Tab, BID
AUCτ,ss of DHP2306R1 and DHP2306R2
Systemic exposure of DHP2302R1 and DHP2302R2
Time frame: At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period
Cmax of DHP2306R1 and DHP2306R2
Plasma concentrations of DHP2306R1 and DHP2306R2
Time frame: At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period
AUC0-48 of DHP2306R1 and DHP2306R2
Secondary pharmacokinetic parameters of DHP2306R1 and DHP2306R2
Time frame: At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period
AUCinf of DHP2306R1 and DHP2306R2
Secondary pharmacokinetic parameters of DHP2306R1 and DHP2306R2
Time frame: At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period
Tmax of DHP2306R1 and DHP2306R2
Secondary pharmacokinetic parameters of DHP2306R1 and DHP2306R2
Time frame: At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period
t1/2 of DHP2306R1 and DHP2306R2
Secondary pharmacokinetic parameters of DHP2306R1 and DHP2306R2
Time frame: At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period
CL/F of DHP2306R1 and DHP2306R2
Secondary pharmacokinetic parameters of DHP2306R1 and DHP2306R2
Time frame: At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period
Vz/F of DHP2306R1 and DHP2306R2
Secondary pharmacokinetic parameters of DHP2306R1 and DHP2306R2
Time frame: At baseline(Day 1 0 hours), Administration day (Day 4 to Day 5) in each period
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Daehwa Pharmaceutical Co., Ltd.