KCT0008519
Completed
未知
A randomized, open-label, multiple-dose, crossover study to compare the safety, pharmacokinetics and pharmacodynamics of DHNP-2001A to RD-01 in healthy adult subjects
DaehanNupharm0 sites44 target enrollmentTBD
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- DaehanNupharm
- Enrollment
- 44
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Healthy adults aged 19 to 55 at the time of screening test
- •2\) Those who weigh not less than 50\.0 kg and not more than 90\.0 kg and have a BMI of not less than 18\.0 kg/m2 but not more than 28\.0 kg/m2 at the time of screening test
- •? Body mass index (kg/m2\) \= Weight (kg)/\[Height (m)]2
- •3\) Those who were tested negative for serum Helicobacter pylori anibody
- •4\) A person who has heard and fully understood this clinical trial and has voluntarily decided to participate and has agreed in writing to comply with the precautions
- •5\) A person who is suitable as a test subject when judging a tester through physical examination, clinical laboratory examination, questionnaire, etc
Exclusion Criteria
- •1\) A person who has or has a history of diseases corresponding to clinically significant hepatabiliary system, kidney, nervous system, immune system, respiratory system, digestive system, endocrine system, blood • tumor, cardiovascular system, urinary system, psychiatric disease, etc
- •2\) A person who has a history of hypersensitivity to drugs and other drugs (aspirin, antibiotics, etc.) containing the same family, or of clinically significant hypersensitivity reactions
- •3\) Gastrointestinal diseases (gastrointestinal ulcers, gastritis, gastric cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may affect the safety and pharmacokinetic evaluation of clinical trial drugs (except simple appendectomy, hernia surgery)
- •4\) A person who has shown the following results in a screening test
- •\- Blood AST (SGOT), ALT (SGPT) \> Normal Range Upper Limit × 1\.5
- •\- Serum test (Hepatitis B test, Hepatitis C test, Human Immunodeficiency Virus (HIV) test) results positive
- •5\) Those who are unable to insert and maintain the pH monitor catheter due to anatomical problems
- •6\) A person who has a history of drug abuse or has tested positive for an abused drug in a urine screening test
- •7\) A person who has taken a specialized drug within two weeks prior to the first scheduled date of administration of a clinical trial drug, or has taken any general drug, health functional food, vitamin preparation or herbal medicine within one week, or is expected to be taken
- •8\) A person who has taken a drug metabolite enzyme\-induced and inhibitory drug, such as a barbiturate drug, within one month prior to the first scheduled administration of a drug for clinical trials
Outcomes
Primary Outcomes
Not specified
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