Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2018-05-25

Brief Summary

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This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive control, and crossover study. Volunteers will be mainly checked up through ECG to find out changes of QT/QTc interval during the study.

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Detailed Description

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Conditions

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Qt Interval, Variation in

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Celecoxib, Moxifloxacin, Water in order

1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days

Wash-out period (3\~6 days)
2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day

Wash-out period (3\~6 days)
3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 400mg capsule

Moxifloxacin

Intervention Type DRUG

Moxifloxacin 400mg tablet

Water

Intervention Type OTHER

Pure water 150ml

Celecoxib, Water, Moxifloxacin in order

1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days

Wash-out period (3\~6 days)
2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day

Wash-out period (3\~6 days)
3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 400mg capsule

Moxifloxacin

Intervention Type DRUG

Moxifloxacin 400mg tablet

Water

Intervention Type OTHER

Pure water 150ml

Moxifloxacin, Water, Celecoxib in order

1. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day

Wash-out period (3\~6 days)
2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day

Wash-out period (3\~6 days)
3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 400mg capsule

Moxifloxacin

Intervention Type DRUG

Moxifloxacin 400mg tablet

Water

Intervention Type OTHER

Pure water 150ml

Water, Moxifloxacin, Celecoxib in order

1. Intervention Pure water: Water 150ml by mouth without any drug, once for one day

Wash-out period (3\~6 days)
2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day

Wash-out period (3\~6 days)
3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 400mg capsule

Moxifloxacin

Intervention Type DRUG

Moxifloxacin 400mg tablet

Water

Intervention Type OTHER

Pure water 150ml

Interventions

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Celecoxib

Celecoxib 400mg capsule

Intervention Type DRUG

Moxifloxacin

Moxifloxacin 400mg tablet

Intervention Type DRUG

Water

Pure water 150ml

Intervention Type OTHER

Other Intervention Names

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Celebrex Avelox

Eligibility Criteria

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Inclusion Criteria

* Healthy adults between 19-year-old and 40-year-old during the screening day
* BMI between 19 kg/m² and 30 kg/m² during the screening day
* Be able to give an informed consent form after understanding for reasonable explanation of clinical trial's purpose, contents and characteristics of clinical drugs
* Wiling to participate whole clinical trial periods

Exclusion Criteria

* Person who is able to clinically affect to the study through ECG result during the screening day
* Has critical issue for Torsade de points from heart failure, hypopotassemia, arrhythmia etc., or family history for long QT syndrome, sudden cardiac death.
* Was suffered, or is suffering from like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study
* Has allergy which is required the treatment or hypersensitive from drugs such as aspirin, anti-biotics, anti-depressants, etc.
* Was administered any drug of other clinical study within 90 days from the randomization day.
* Donated whole blood within 60days or apheresis within 30 days from the randomization day.
* Took any medicine or oriental medicine within 2 weeks, or general pharmaceuticals within 7 days from the randomization day. (For general pharmaceuticals circumstances, PI could decide whether he/she is suitable for the study)
* No intention to take contraceptive which is approved as clinical way, or is planning on giving their sperm or egg during the whole clinical trial.
* Average alcohol consumption per week: \>140g
* Average smoking per day: \>20
* Average grapefruit juice consumption per day: \>4 glasses
* systolic blood pressure \<100 mmHg or \>150 mmHg, or diastolic pressure \<70 mmHg or \>100mmHg
* Over 2 times from the maximum reference interval of AST and ALT levels in the blood.
* eGFR by MDRD from creatinine in the blood is less than 30 mL/min.
* doesn't show negative reaction from HIV Test, B hepatitis test, or C hepatitis test
* For woman, doesn't show negative reaction from pregnancy test
* PI decides the person is not suitable to participate the clinical study with other reasons.

Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes