Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IN-A012; Drug: Akynzeo 300Mg-0.5Mg Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT04486157

IN_FNP_101

Details and patient eligibility

About

The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation

Full description

[Pharmacokinetics Assessment]

• Primary Parameter

  • AUC0-t

• Secondary Parameters - Cmax, tmax

[Safety Assessment]

• Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests

Enrollment: 44 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults aged between 19-45
2. Body weight ≥ 50kg and in the range of ideal body weight ± 20%
3. Without congenital, or chronic diseases within recent 5 years
4. Subjects who are deemed eligible based on the screening tests
5. 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
6. Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product
7. Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.

Exclusion criteria

1. A subject with symptoms suspected of acute illness at the screening
2. A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors
3. A history of gastrointestinal disease
4. Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity
5. A history of drug abuse
6. Pregnant women or women who may be pregnant, and breastfeeding women
7. Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

IN-A012

Experimental group

Description:

Intravenous administration of IN-A012

Treatment:

Drug: IN-A012

Akynzeo capsules

Active Comparator group

Description:

Single oral administration of Akynzeo capsules

Treatment:

Drug: Akynzeo 300Mg-0.5Mg Capsule