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

NCT04325009 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-03-27

No results posted yet for this study

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

Interventions

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"

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • SeungHyun Kang, Ph.D · H Plus Yangji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2020-05-31
Completion
2020-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04325009 on ClinicalTrials.gov