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Completed

NCT Number: NCT02071381

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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center IRB

Seoul, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DW330SR 45mg

Drug

DW1030 75mg

Drug

Primary outcomes

  1. Trans-OH as Main Metabolites of DW330SR, DW330SR, Cmax, AUClast of DW1030

    Time frame: -28 ~ -2day(screening), -1day, 1day, 2day

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 25, 2014
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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