Skip to content

An integrative pharmacogenetic-pharmacometabolomic study to predict individualized pharmacokinetics of metoprolol in healthy male subjects

An integrative pharmacogenetic-pharmacometabolomic study to predict individualized pharmacokinetics of metoprolol in healthy male subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0000449
Enrollment
16
Registered
2012-05-24
Start date
2011-12-05
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Genetic : Betaloc tab 100 mg, single dose, oral administration

Sponsors

Kyungpook National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 150mmHg or diastolic > 100mmHg)made during the screening period or current diagnosis of hypertension 4.Resting pulse rate of 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.

Design outcomes

Primary

MeasureTime frame
AUC

Countries

Korea, Republic of

Contacts

Public ContactYoung-Ran Yoon

Kyungpook National University Hospital

yry@knu.ac.kr+82-53-420-4950

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026