Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Viread® tablet; Drug: CKD-390

Study type: Interventional

Funder types: Industry

Identifiers

NCT02589457

163BE15028

Details and patient eligibility

About

The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.

Full description

A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers

Enrollment: 40 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy male volunteer in the age of 19-45
2. Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20%
3. Subject without a hereditary problems, chronic disease and morbid symptom
4. Subject who sign on an informed consent form willingly

Exclusion criteria

1. Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
2. Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy)
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives
4. Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
5. Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
6. Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range
7. Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
8. The history of drug abuse or drug abuse showed a positive for urine drug test
9. Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 1 month
10. Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
11. Taking drugs have received any other investigational drug within 3 months prior to the first dosing
12. Whole blood donation within 2 months prior to the first dosing or component blood donation within 1 months prior to the first dosing or blood transfusion within 1 month
13. Continuously taking excessive alcohol (> 21 units/week; 1 unit = 10g of pure alcohol) or cannot stop drinking from 24 hours before admission to discharge
14. Cigarette > 10 cigarettes a day on average for recent 3 months
15. Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
16. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Viread® tablet

Active Comparator group

Description:

Tenofovir Disoproxil Fumarate

Treatment:

Drug: Viread® tablet

CKD-390

Experimental group

Description:

Tenofovir Disoproxil Fumarate

Treatment:

Drug: CKD-390