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

Daewon Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: DW1030 75mg

Drug: DW330SR 45mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02071381

DW340-1001

Details and patient eligibility

About

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

Sex

Male

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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