Status:
UNKNOWN
Bioequivalence Study Between "Dong-A Atorvastatin Tab" and "Lipitor Tab"
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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"...
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 h...
Eligibility Criteria
Inclusion
- A person who aged 19 or older at the time of screening
- BMI of 18 to 30 (BMI calculation: kg/m2)
- Males weighing 50kg or more
- Females weighing 45kg or more
- No congenital or chronic diseases or pathological symptoms
- A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
- 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
- A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP
Exclusion
- 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
- A person who has participated in other clinical trials within six months prior to the first administration of the IP
- A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP
- A person who has medical history of gastric resection that can affect the drug absorption
- 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)
- 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
- A person who has medical history of mental disease
- A person who is judged not to be suitable for the study by the investigator
- Lactating or possibly pregnant women
Key Trial Info
Start Date :
March 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04325009
Start Date
March 30 2020
End Date
August 1 2020
Last Update
March 27 2020
Active Locations (1)
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1
H Plus Yangji Hospital
Seoul, South Korea, 08779