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Clinical Trials for Pharmacological Standardization of Herbal Preparation

Pharmacological Standardization of Herbal Preparation as part of the business for 10 kinds of herbs standardized indicators for the quality and quantity of ingredients to make a single institution, researchers led by a single group, phase 1 clinical trial drug pharmacokinetics

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0000813
Enrollment
100
Registered
2013-08-12
Start date
2013-01-19
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 : We will perform clinical trial to perform Pharmacological Standardization, and to analysis changes of health related makers such as liver and kidney function maker after oral administration of

Sponsors

Jeollanamdo Development Institute of Korean Traditional Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: - In spite of being over weight over 55kg of weight within a range of ± 20% on the corresponding - No congenital or chronic diseases, internal medicine, including an electrocardiogram findings jeokin examination results or who does not have psychotic symptoms. - Doctor of medicine, depending on the characteristics set, conducted blood pathology, blood chemistry tests, urine tests, including clinical pathology in subjects who have been determined to be suitable.

Exclusion criteria

Exclusion criteria: - Clinically significant liver, kidney, nervous system, immune system, respiratory, musculoskeletal, endocrine, etc. to the disease or the blood, tumor diseases, cardiovascular diseases, mental illness, or who have a history. - Testing of drugs that may affect the absorption of gastrointestinal disease or who have a history of gastrointestinal surgery. - More than three minutes after the break loci in the measured vital signs = 160mmHg systolic blood pressure = 90mmHg or = 100mmHg or diastolic blood pressure = 60mmHg or equivalent to the carriers. - Now more than usual, or 30g/day alcohol alcohol consumption during the week clinical trial who are not able to. - Xanthine (coffee, tea, cola) beverages containing 4cup / day more than those who consume. - Smoking more than 20 cigarettes a day cigarette or its smoke under, but who can not stop smoking, medication and blood sampling period. - Drug clinical trial within 30 days of the first dose of barbital kinds of drugs, such as drug metabolism, enzyme induction and inhibition of drug taking and excessive drinking, and characters. - A history of drug abuse or misuse interview and physical examination on the person concerned is suspected drugs. - Drug clinical trial within 90 days before the first dose bioequivalence studies other or other parties who have participated in clinical trials. - Chonnam National University Hospital provides a standard meal in the party that can not be. - Clinical laboratory test results due to other reasons, including participation in clinical trials tester who deems inappropriate.

Design outcomes

Primary

MeasureTime frame
Measured at each sampling time with the concentration of the blood plasma concentration-time area under the curve, ;maximum plasma concentratime ;time to reach maximum plasma concentration; elimination velocity constant;elimination half life.

Countries

Korea, Republic of

Contacts

Public ContactLee Ah

Chonnam National University Hospital

Outcome results

None listed

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