KCT0009163
Completed
未知
Phase 1 study to evaluate the pharmacokinetics and the safety of KDF2001 in healthy adult volunteers
Kyung Dong Pharmaceutical0 sites40 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic diseases
- Sponsor
- Kyung Dong Pharmaceutical
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) 19 years old or older at screening visit
- •2\) weighed 50 kg or more (45 kg or more for female) with body\-mass index of 18 to 30 kg/m^2 at screening visit
- •3\) neither clinically significant congenital or chronic diseases, nor pathologic symptoms or findings in medical examinations at screening visit
- •4\) eligible in laboratory tests and electrocardiogram
- •5\) proper contraception for volunteer and his/her partners, restrictions of sperm or egg donation throughout the study
- •6\) voluntary sign on informed consent form after fully understating the study.
Exclusion Criteria
- •1\) clinically significant gastrointestinal, cardiovascular, endocrine, respiratory, hematologic, oncologic, infectious, nephrologic, urologic, psychologic, musculoskeletal, immunologic, otolaryngologic, dermatologic, or ophthalmologic diseases or history.
- •2\) gastrointestinal surgery or disease affecting absorption of oral medications
- •3\) drug metabolism inducers or inhibitors within 1 month, or clinical trial\-interfering medications within 10 days
- •4\) other investigational products withing 6 months
- •5\) whole blood donation within 8 weeks, apheresis within 2 weeks, or blood transfusion within 4 weeks
- •6\) following conditions within 1 month
- •6\-1\) alcohol consumption over 21 drinks per week for male, over 14 drinks per female
- •6\-2\) smoking over 20 cigarettes a day
- •7\) following conditions
- •7\-1\) hypersensitivity to active ingredients or excipients of investigational products
Outcomes
Primary Outcomes
Not specified
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