Assessment of Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea.

Inclusion criteria

• Subjects with chronic functional Diarrhea. (included Irritable Bowel Syndrome with perdominant diarrhea(IBS-D)).
• Male or Female subjects aged between 19 and 60 years at screening.
• Body Mass Index(BMI) between 18 and 27kg/m2 in male, 17 and 26kg/m2 in female. ※ BMI (kg/m2) = body weight (kg)/[height (m)]2
• Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information.

Exclusion criteria

• No history or clinically significant symptoms or severe disease, including cardiac, neurological, pulmonary, hepatic, biliary, gastrointestinal, endocrinologic, or renal disorders, or cancer.
• Identified or strongly suspected organic cause to diarrhea.
• Celiac disease or Intestinal malabsorption, Unspecified intestinal malabsorption.
• History of any serious adverse reaction or adverse event or hypersensitivity to any component of investigational product.
• Constipation, Iron deficiency anaemia, Hypocalcaemia, Osteoporosis.
• Known domestic, leisure or professional exposure to elemental impurities.
• Women who are breastfeeding or are planning to become pregnant during the study.
• Positive pregnancy test at screening.
• Presence of clinically significant physical, laboratory, vital signs, or ECG findings.
• Blood lead level > 3.3 μg/dL(=33.0 μg/L) at screening.
• galactose intolerance, fructose intolerance, Lapp lactase deficiency, sucurase-isomaltase deficiency, glucose-galactose malabsorption.
• Receipt of any investigational agent or study drug within 4 weeks prior to screening.
• Patients with history of alcohol or drug abuse.
• Subjects who donated whole blood within 2 months, donated blood components within 1 month.
• Subjects who have participated and taken investigational drug within 1 month prior to study drug administration.
• Subjects who the investigator considers inappropriate for the study due to other reasons.