None listed
Conditions
Interventions
Drug : - KP-01 (Ferric maltol)
- Code name: KP-01
- Product name: ACCRUFER
- Medicinal ingredient and content: Ferric maltol 231.5 mg in 1 capsule
- 24 in total (12 for each dosage group)
- Dosage gro
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who are adult volunteers aged 18 ~ 55 at the time of the screening test 2) Subjects with Body Mass Index (BMI) of 18.0 kg/m2 ~ 28.0 kg/m2 at the time of the screening test - Body Mass Index, kg/m2 = weight(kg)/{height(m)}2 3) Subjects with ferritin < 30 µg/L, or ferritin < 50 µg/L and transferrin saturation (TSAT) < 20% at the time of the screening test 4) Subjects with hemoglobin (Hb) = 8.5 g/dL measured at the time of the screening test, regardless of anemia symptoms 5) Subjects who have full understanding of this clinical trial after sufficient explanation, have voluntarily decided to participate, and submitted their written consent for compliance with the precautions
Exclusion criteria
Exclusion criteria: 1) Subjects who have diseases that can induce impaired absorption of the investigational drug (ex. short bowel syndrome, malabsorption syndrome, and celiac disease) 2) Subjects who have received gastrointestinal resection that can influence the absorption of the investigational drug (ex. gastrectomy, gastric bypass surgery, and enterectomy) 3) Subjects who have a history of hypersensitivity reaction to the ingredients of the investigational drug, same drug class, or drugs containing iron, or history of clinically significant hypersensitivity reaction 4) Subjects who have hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 5) Subjects who have diseases that require restriction of iron replacement drugs (ex. hemochromatosis, chronic hemolytic anemia, thalassemia, and sideroblastic anemia) 6) Subjects with ongoing infective disease 7) Subjects who have inflammatory bowel disease that is uncontrolled, leading to discomfort in daily living, or severe inflammatory bowel disease (CDAI score = 220 in the case of Crohn’s disease, and Mayo score = 6 in the case of ulcerative colitis) 8) Subjects with the following results in the screening tests, including additional tests ? Blood level of AST (SGOT), ALT (SGPT) > upper limit of normal range × 2.0 ? Blood level of Creatinine > upper limit of normal range × 1.5 9) Subjects with positive results for serologic tests (hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV), and syphilis) 10) Subjects who have a history of drug abuse, or who showed positive results for drug abuse in the urine screening test 11) Subjects who were administered with iron replacement drugs in the form of injection within 28 days prior to the first planned administration of the investigational drug 12) Subjects who were administered with oral iron replacement drugs within 7 days prior to the first planned administration of the investigational drug 13) Subjects who were administered with erythropoiesis stimulating agents within 28 days prior to the first planned administration of the investigational drug 14) Subjects who were administered with the investigational drug in a separate clinical trial (including bioequivalence trials) within 6 months prior to the first planned administration of the investigational drug 15) Subjects who were administered with the investigational drug in a separate clinical trial (including bioequivalence trials) within 6 months prior to the first planned administration of the investigational drug 16) Subjects who have diseases that are accompanied by profuse bleeding (excluding menstrual bleeding in female subjects) 17) Female subjects who are pregnant, breastfeeding, or have plans of pregnancy 18) Subjects who are not able to take the iron-restricted diet required for the duration of the clinical trial 19) Subjects (or their spouses or partners) who cannot, or will not use medically permitted contraceptive method for the whole duration of the clinical trial and for at least 4 weeks following the final administration of the investigational drug, and subjects who meet at least one of the following conditions ? Male - Subjects who do not agree to refrain from sperm donation for the above duration ? Female - Subjects who do not agree to refrain from ovum donation for the above duration - Subjects who were confirmed to be positive in a pregnancy test - Fertile subjects (who experienced menarche, have not received successful contraceptiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total serum iron concentration and TSAT | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma maltol, plasma maltol glucuronide concentrations | — |
Countries
Korea, Republic of
Contacts
Public ContactMinji Oh
Seoul National University Hospital
Outcome results
None listed