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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589457
• Other study ID #: 163BE15028
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2015
• Last updated: January 11, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• CKD-390
Tenofovir Disoproxil Aspartate 1T PO
• Viread® tablet
Tenofovir Disoproxil Fumarate 1T PO

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon	Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of Tenofovir		0(Pre-dose) up to 72hr	No
Secondary	AUCinf		0(Pre-dose) up to 72hr	No
Secondary	Blood pressure		1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day	Yes
Secondary	tmax		0(Pre-dose) up to 72hr	No
Secondary	t1/2ß		0(Pre-dose) up to 72hr	No
Secondary	Clearance/F		0(Pre-dose) up to 72hr	No
Secondary	Electrocardiography		1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day	Yes
Secondary	Physical Examination		1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day	Yes
Secondary	Pulse rate		1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day	Yes
Secondary	Temperature		1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day	Yes