Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: Naproxen; Drug: DWP14012; Drug: Celecoxib; Drug: Meloxicam

Study type: Interventional

Funder types: Industry

Identifiers

NCT04490434

DW_DWP14012005

Details and patient eligibility

About

drug-drug interaction between DWP14012 and three different kinds of NSAIDs

Full description

to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers

Enrollment: 110 estimated patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
• Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

Exclusion criteria

• Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
• Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
• Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
• Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
• Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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110 participants in 6 patient groups

Cohort 1, A (DWP14012/Celecoxib)

Experimental group

Description:

Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.

Treatment:

Drug: Celecoxib

Drug: DWP14012

Cohort 1, B (DWP14012/Celecoxib)

Experimental group

Description:

Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.

Treatment:

Drug: Celecoxib

Drug: DWP14012

Cohort 2, C (DWP14012/Naproxen)

Experimental group

Description:

Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.

Treatment:

Drug: Naproxen

Drug: DWP14012

Cohort 2, D (DWP14012/Naproxen)

Experimental group

Description:

Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.

Treatment:

Drug: Naproxen

Drug: DWP14012

Cohort 3, E (DWP14012/Meloxicam)

Experimental group

Description:

Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.

Treatment:

Drug: Meloxicam

Drug: DWP14012

Cohort 3, F (DWP14012/Meloxicam)

Experimental group

Description:

Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.

Treatment:

Drug: Meloxicam

Drug: DWP14012