An integrative pharmacogenetic-pharmacometabolomic study to predict individualized pharmacokinetics of metoprolol in healthy male subjects
- Conditions
- Not Applicable
- Registration Number
- KCT0000449
- Lead Sponsor
- Kyungpook National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 16
1.Healthy male subjects between the ages of 20 and 50 years at screening;
2.Subjects with a body weight within ± 20% of their ideal weight;
3.Subjects must be in generally good health as determined by pre-study medical history and physical examination, with no congenital or chronic diseases;
4.Subjects must be able to read, understand, and willing to decide to participate in the study, follow the study directions and provide written informed consent.
1.Hypersensitivity to the study medication or any related medication, including any other constituents of the formulation or past history of allergic reaction;
2.Presence or history of cardiovascular, pulmonary, renal, endocrine, hematologic, gastrointestinal, central nervous system, psychiatric, or malignant disease;
3.Diagnosis of hypotension (systolic < 105mmHg or diastolic < 65 mg) or hypertension (systolic > 150mmHg or diastolic > 100mmHg)made during the screening period or current diagnosis of hypertension
4.Resting pulse rate of < 50 beats per minute during the screening period.
5.History of alcohol abuse (>21 units/week) or subjects who are not willing to abstain from drinking for the duration of study;
6.A history of serious trauma within 4 weeks, or resection operation (excluding simple appendectomy or herniorrhaphy) and/or relevant history or laboratory or clinical findings indicative of acute disease
7.A history of drug abuse.
8.Use of any prescription drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to administration of study drug;
9.Use of any other investigational drug within 3 months prior to administration of study drug;
10.Donation of whole blood within 2 months or any blood products within 1 month, prior to administration of study drug;
11.Excessive smoking (>10 cigarettes/day)
12.Any abnormal diet, likely to influence absorption, distribution, metabolism, and excretion of the drug (e.g. habitually taking more than 1L of grapefruit juice/day within 7 days prior to administration of study drug)
13.Positive test result for hepatitis (B or C) or HIV or VDRL
14.Subject who is not eligible to participate in this study, as judged by an investigator.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC
- Secondary Outcome Measures
Name Time Method