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

• Sponsor: Dong-A ST Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04325009
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.1
• Patients Per Site Per Month: 13.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab; Drug: Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab	Phase 1

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.

1. Wash out period: at least 7 days

2. 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)

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Crossover Assignment single-dose, 2-sequence, 4-period Bioequivalence StudyCrossover Assignment single-dose, 2-sequence, 4-period Bioequivalence Study
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Anticipated Study Start Date: Mar 30, 2020
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: Aug 1, 2020

Arms and Interventions

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"

Outcome Measures

Primary Outcome Measures

1. Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin [Before administration ~ 36hrs]

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

2. Peak Plasma Concentration(Cmax) of Atorvastatin [Before administration ~ 36hrs]

   Peak Plasma Concentration(Cmax) of Atorvastatin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. No congenital or chronic diseases or pathological symptoms

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

3. 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

4. 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)

1. 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

2. A person who has medical history of mental disease

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

4. Lactating or possibly pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Plus Yangji Hospital	Seoul		Korea, Republic of	08779

Sponsors and Collaborators

• Dong-A ST Co., Ltd.

Investigators

• Principal Investigator: SeungHyun Kang, Ph.D, H Plus Yangji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dong-A ST Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04325009
• Other Study ID Numbers: DDS19-066BE
• First Posted: Mar 27, 2020
• Last Update Posted: Mar 27, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atorvastatin

Study Results

No Results Posted as of Mar 27, 2020