A Study to Evaluate the Effect of Gumiganghwaltang on the Pharmacokinetics of Caffeine after Oral Administration of Caffeine in Healthy Male Volunteers
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001812
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 8
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
- 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 < 13.0 g/dL, AST or ALT > 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) < 60 mL/min/1.73 m2)
- Systolic blood pressure = 140mmHg or = 90mmHg, diastolic blood pressure = 90mmHg or = 60mmHg after taking 5 minitues of rest.
- Subjects who have drug abuse history
- Subjects who take too much caffeine, alcohol and smoking (caffeine > 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)