Phase 1 Study of DDI Between DW330SR and DW1030 in Healthy Male Subjects

A Randomized, Open Label, Single-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between DW330SR and DW1030 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02071381

Enrollment

Unknown

Registered

2014-02-25

Start date

2014-04-30

Completion date

2014-06-30

Last updated

2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this study is to evaluate drugs interactions to compare pharmacokinetics in groups of monotherapy DW330SR, monotherapy DW1030, and coadministration DW330SR and DW1030

Interventions

DRUGDW330SR 45mg

DRUGDW1030 75mg

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Inclusion criteria

* Healthy Adult males aged 20\ 40 years at screening visit * Subjects with range of 19 kg/m2 \ 27 kg/m2 as BMI measurements at screening visit * Subjects with BP range of below: 90 mmHg ≤ Systolic BP ≤ 140 mmHg 50 mmHg ≤ Diastolic BP ≤ 90mmHg * Subjects who voluntarily agreed with written consent that be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the reguirement of the study

Exclusion criteria

* Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.) * Subjects with history of gastrointestinal disease (ex, Chrones dz, peptic ulcer, etc) affect the absorption of Investigational drugs or history of surgery (except for a simple appendectomy or hernia surgery) * Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID and antibiotics) including ingredient of DW330SR and DW1030 and Food

Design outcomes

Primary

Measure	Time frame
Trans-OH as Main Metabolites of DW330SR, DW330SR, Cmax, AUClast of DW1030	-28 ~ -2day(screening), -1day, 1day, 2day

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026