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Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers

An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Drug Interaction Between DWC20141 and DWC20142 in Healthy Adult Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02369302
Enrollment
30
Registered
2015-02-23
Start date
2015-01-31
Completion date
2015-06-30
Last updated
2016-03-01

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 the pharmacokinetics profile and drug-drug interaction between DWC20141 and DWC20142 in healthy adult subjects.

Interventions

DRUGDWC20141

Tablet

DRUGDWC20142

Tablet

DRUGDWC20141, DWC20142

Tablet

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. Healthy adult male volunteers aged 19 to 45 years 2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result 3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion criteria

1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history. 2. A subject who shows the following result in clinical laboratory test * AST, ALT \> 1.25 times of the upper limit of normal range * PR ≥ 210 msec * QRS ≥ 120 msec * QT ≥ 500 msec * QTcF ≥ 500 msec 3. Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.

Design outcomes

Primary

MeasureTime frame
Cmax,ssMultiple blood sample will be collected for 24 hours after last dosing in each of the periods
AUCtauMultiple blood sample will be collected for 24 hours after last dosing in each of the periods

Secondary

MeasureTime frame
Cmin,ssMultiple blood sample will be collected for 24 hours after last dosing in each of the periods
TmaxMultiple blood sample will be collected for 24 hours after last dosing in each of the periods
t1/2Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Metabolic RatioMultiple blood sample will be collected for 24 hours after last dosing in each of the periods

Countries

South Korea

Outcome results

None listed

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