NCT04325009

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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"
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"

Timeline

• Start date: 2020-03-30
• Primary completion: 2020-05-01
• Completion: 2020-08-01
• First posted: 2020-03-27
• Last updated: 2020-03-27

Locations

1 site across 1 country: South Korea