Status:
COMPLETED
Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
Detailed Description
\[Pharmacokinetics Assessment\] * Primary Parameter \- AUC0-t * Secondary Parameters - Cmax, tmax \[Safety Assessment\] \- Adverse events, vital signs, physical examination, 12-lead ECGs, and cl...
Eligibility Criteria
Inclusion
- Healthy adults aged between 19-45
- Body weight ≥ 50kg and in the range of ideal body weight ± 20%
- Without congenital, or chronic diseases within recent 5 years
- Subjects who are deemed eligible based on the screening tests
- Subjects who received a full explanation of the study, understood the purpose and details of this study, characteristics of the investigational product, and expected adverse events, and voluntarily signed the informed consent form
- Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product
- Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.
Exclusion
- A subject with symptoms suspected of acute illness at the screening
- A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors
- A history of gastrointestinal disease
- Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity
- A history of drug abuse
- Pregnant women or women who may be pregnant, and breastfeeding women
- Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04486157
Start Date
March 18 2021
End Date
May 10 2021
Last Update
June 1 2021
Active Locations (1)
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1
Catholic Univ. of Seoul St. Mary's Hospital
Seoul, South Korea