None listed
Conditions
Interventions
Drug : Han-Poong Gumiganghwal-tang (GGT)
4.01g / pouch, 3 pouch / 1 day, 3 times / 1 day (9am, 3pm, 9pm)
2 dyas oral administration (3rd and 4th day in the hospital).
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Healthy adult male volunteers aged 19 to 45 years - Subjects who have over 55kg and within ±20% of ideal body weight * IBW= (height (cm) - 100) × 0.9 - Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period
Exclusion criteria
Exclusion criteria: - Subjects with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history. - Subjects who have gastrointestinal disease (Crohn’s disease, peptic ulcer, acute or chronic pancreatitis) which may affect absorption of GGT or who have past medical history in gastrointestinal surgery (excluding simple appendectomy or herniotomy). - Subjects who have hypersensitivity to clinical trial medications or additives, or who have past medical history of clinically significant hypersensitive reaction. - Subjects who are considered inappropriate subjects after screening test(medical history, physical examination, vital sign, ECG, laboratory test, etc) - Subjects who show any following result in clinical laboratory test (Hemoglobin 1.5 times of upper limit of normal range / Total bilirubin > 1.5 times of upper limit of normal range / CPK > over 1.5 times of upper limit of normal range / eGFR(estimated Glomerular Filtration Rate) by using MDRD(Modification of Diet in Renal Disease) 5 cups/day, alcohol > 210g/week, cigarette > 10 pieces/day) - Subjects who have taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication. - Subjects who took drugs like barbiturates which induce or inhibit the enzyme involved in drug metabolism within 30 days. - Subjects who donated whole blood within 60 days or specific components of the blood within 30 days before taking clinical trial medication. - Subjects who took food containing grapefruit within 7 days before being administered clinical trial medication - Subjects who took Western medicine or herb medicine before being administered clinical trial medication or subjects who took OTC or vitamins within 7 days before being administered clinical trial medication. - Subjects who are considered inappropriate for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The peak plasma concentration of caffeine after caffeine administration (Cmax);The area under the plasma concentration-time curve of caffeine from zero to the last quantifiable concentration (AUC(last)) | — |
Secondary
| Measure | Time frame |
|---|---|
| The area under the plasma concentration-time curve of caffeine from zero to infinity (AUC(inf));Time to reach Cmax of caffeine (tmax);Terminal half-life of caffeine;The peak plasma concentration of caffeine major metabolites (Theobromine, Paraxanthine, Theophylline) after caffeine administration (Cmax) ;The area under the plasma concentration-time curve of caffeine major metabolites (Theobromine, Paraxanthine, Theophylline) from zero to the last quantifiable concentration (AUC(last));The area under the plasma concentration-time curve of caffeine major metabolites (Theobromine, Paraxanthine, Theophylline) from zero to infinity (AUC(inf));Time to reach Cmax of caffeine major metabolites (Theobromine, Paraxanthine, Theophylline) (tmax);Terminal half-life of caffeine major metabolites (Theobromine, Paraxanthine, Theophylline) (t1/2) | — |
Countries
Korea, Republic of
Contacts
Public ContactJunhee Lee
Kyung Hee University Oriental Medical Center
Outcome results
None listed