Healthy Clinical Trial
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
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
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
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