Bioequivalence Study Between "Dong-A Atorvastatin Tab" and "Lipitor Tab"

NCT ID: NCT04325009

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-30
• Study Completion Date: 2020-08-31

Brief Summary

An Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers

Detailed Description

1. Study design: An open-Label, randomized, 2-sequence, 4-period, fasting condition, single-dose, per oral, cross-over study

2. Administration method:

The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (Dong-A Atorvastatin 80mg or Lipitor 80mg) with 150 mL of water at around 8 a.m. on the day of the test. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the blood collection time.

3. Wash out period: at least 7 days

4. Blood collection time: Before the administration, 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12, 24, 36 hr after the administration (total 16 times)

5. Analysis: Measurement of the concentration of an unchangeable substance of Atorvastatin in plasma

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

RTRT

R: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab"

Group Type: EXPERIMENTAL

Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab

Intervention Type: DRUG

1. st period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days

2. nd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days

3. rd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days

4. th period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab"

TRTR

R: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab"

Group Type: EXPERIMENTAL

Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab

Intervention Type: DRUG

1. st period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days

2. nd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days

3. rd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days

4. th period: single oral administration of 1 tablet of "Lipitor 80mg Tab"

Interventions

Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab

1. st period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days

2. nd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days

3. rd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days

4. th period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab"

Intervention Type: DRUG

Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab

1. st period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days

2. nd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days

3. rd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days

4. th period: single oral administration of 1 tablet of "Lipitor 80mg Tab"

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. A person who aged 19 or older at the time of screening

2. BMI of 18 to 30 (BMI calculation: kg/m2)

• Males weighing 50kg or more
• Females weighing 45kg or more

3. No congenital or chronic diseases or pathological symptoms

4. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination

5. A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature

6. A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP

Exclusion Criteria

1. A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of IP

2. A person who has participated in other clinical trials within six months prior to the first administration of the IP

3. A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP

4. A person who has medical history of gastric resection that can affect the drug absorption

5. A person with a history of regular alcohol intake within a month prior to the first administration of the IP:

• Male: More than 21 cups/week
• Female: More than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits)

6. A person who is hypersensitive to any of the IP components, taking glecaprevir, pibrentasvir, has active hepatic disease, Blood AST (GOT) or ALT (GPT) levels exceed the upper reference range limit by 3 times, muscle disease, or any genetic symtoms such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

7. A person who has medical history of mental disease

8. A person who is judged not to be suitable for the study by the investigator

9. Lactating or possibly pregnant women

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SeungHyun Kang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

H Plus Yangji Hospital

Locations

H Plus Yangji Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

SeungHyun Kang, Ph.D

Role: CONTACT

juspa@naver.com

82-070-4665-9490

Facility Contacts

SeungHyun Kang

Role: primary

juspa@naver.com

82-070-4665-9490

Other Identifiers

DDS19-066BE

Identifier Type: -

Identifier Source: org_study_id