None listed
Conditions
Interventions
Dietary Supplement : Twelve participants will be randomized equally to sequence A or B. Under the test condition (T), participants will receive a single oral administration of two tablets of Hyeoldang
sequence B will receive R in Period 1 followed by T in Period 2. Periods 1 and 2 occur on Day 1 and Day 15, respectively, with a 14-day washout. One hour after each condition, participants will ingest
Sponsors
Hanyang University Seoul Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 19 to 60 years at the screening visit. 2. Body weight of 50.0 to 90.0 kg and body mass index of 18.0 to 30.0 kg/m² at screening. 3. Considered eligible for the study by the investigator based on physical examination, clinical laboratory tests, medical interview, and other assessments. 4. Voluntarily decides to participate after receiving and fully understanding the study information and provides written informed consent to comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Presence or history of clinically significant hepatobiliary, renal, neurologic, immune, respiratory, gastrointestinal, endocrine, hematologic/oncologic, cardiovascular, urologic, or psychiatric disease. 2. History of gastrointestinal disease, such as Crohn disease or ulcer, or surgery that may affect the oral glucose tolerance test or absorption of either study product; simple appendectomy and hernia repair are excluded from this criterion. 3. History of clinically significant hypersensitivity to any component of Hyeoldang Care Plus or Hyeoldang Care Alpha Stick. 4. Any of the following at screening: aspartate aminotransferase or alanine aminotransferase greater than two times the upper limit of normal; fasting glucose greater than 126 mg/dL; or a positive serologic test for hepatitis B, hepatitis C, or human immunodeficiency virus. 5. After at least 3 minutes of seated rest, systolic blood pressure below 80 mmHg or above 150 mmHg, or diastolic blood pressure below 40 mmHg or above 100 mmHg. 6. Use, or anticipated use, within 2 weeks before the expected first administration of prescription medication or herbal medicine known to significantly affect blood glucose. 7. Whole-blood donation within 2 months, apheresis donation within 1 month, or blood transfusion within 1 month before the expected first administration. 8. Pregnant or breastfeeding women. 9. Participation in another clinical trial and receipt of an investigational medicinal product within 90 days before the first administration of the study products. 10. Considered unsuitable for participation by the investigator because of clinical laboratory findings or any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 0-2-hour area under the concentration-time curve, 2-hour concentration, maximum observed concentration, and time to maximum observed concentration of blood glucose during the oral glucose tolerance test | — |
Secondary
| Measure | Time frame |
|---|---|
| 0-2-hour area under the concentration-time curve, 2-hour concentration, maximum observed concentration, and time to maximum observed concentration of blood insulin during the oral glucose tolerance test | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Won Lee
Hanyang University Seoul Hospital
Outcome results
None listed