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

NCT04325009 | Unknown Phase 1

• 1 other identifier: DDS19-066BE
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin

  Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin

  Before administration ~ 36hrs

• Peak Plasma Concentration(Cmax) of Atorvastatin

  Peak Plasma Concentration(Cmax) of Atorvastatin

  Before administration ~ 36hrs

Study Arms (2)

RTRT

EXPERIMENTAL

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

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

TRTR

EXPERIMENTAL

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

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

Interventions

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

RTRT

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

TRTR

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A person who aged 19 or older at the time of screening
• BMI of 18 to 30 (BMI calculation: kg/m2)
• Males weighing 50kg or more
• Females weighing 45kg or more
• No congenital or chronic diseases or pathological symptoms
• A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
• 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
• A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP

You may not qualify if:

• 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
• A person who has participated in other clinical trials within six months prior to the first administration of the IP
• A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP
• A person who has medical history of gastric resection that can affect the drug absorption
• 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)
• 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
• A person who has medical history of mental disease
• A person who is judged not to be suitable for the study by the investigator
• Lactating or possibly pregnant women

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, 08779, South Korea

RECRUITING

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• SeungHyun Kang, Ph.D

  H Plus Yangji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SeungHyun Kang, Ph.D

CONTACT

82-070-4665-9490; juspa@naver.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover Assignment single-dose, 2-sequence, 4-period Bioequivalence Study

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: March 30, 2020
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

KR (1)