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

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab; Drug: Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab

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

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: SeungHyun Kang, Ph.D; Phone Number: 82-070-4665-9490; Email: juspa@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08779
    • Recruiting
    • H plus Yangji Hospital
    • Contact: SeungHyun Kang; Phone Number: 82-070-4665-9490; Email: juspa@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RTRT; R: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab"	Drug: Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab; st period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days; nd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days; rd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days; th period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab"
Experimental: TRTR; R: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab"	Drug: Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab; st period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days; nd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days; rd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days; th period: single oral administration of 1 tablet of "Lipitor 80mg Tab"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: SeungHyun Kang, Ph.D, H plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2020
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: DDS19-066BE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No