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A Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152

A Randomized, Open-labeled, Oral Dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152 in Healthy Male Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02502721
Enrollment
58
Registered
2015-07-20
Start date
2015-06-30
Completion date
2015-08-31
Last updated
2015-08-25

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

Conditions

Healthy

Keywords

Male

Brief summary

A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

Detailed description

This study is to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects. Study design is randomized, open-labeled, oral dose, crossover design. This study will conducted with 2 separated part (Part A, Part B).

Interventions

DRUGDWC20151
DRUGDWC20152

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy male subjects (18\ 55 years)

Exclusion criteria

* Who has allergy to investigational product

Design outcomes

Primary

MeasureTime frame
Peak Plasma Concentration (Cmax)0~72hr
Area under the plasma concentration versus time curve (AUC)0~72h

Countries

South Korea

Outcome results

None listed

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