A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics after Oral Administration of HIP2101 in Healthy Adult Volunteers

Inclusion Criteria:

• Healthy volunteers in the age between 19 and 50 years old.
• Body mass index (BMI) in the range of 18 to 30 kg/m2 and weight 50.0kg to 90.0kg.
• After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
• Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion Criteria:

• Gastrointestinal disorders (Crohn's disease or Acute/chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
• Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs.
• Aspartate aminotransferase and alanine aminotransferase exceed 2 times the upper limit of normal range from screening laboratory results before randomization.
• Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within 6 months before the first administration or who cannot abstain from consent to post-study visit.
• Heavy smoker (>10 cigarettes/day).