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Clinical trial for Herb standardization project, sponsor-investigator trials, phase 1 pharmacokinetic study

Clinical trial for Herb standardization project

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0001210
Enrollment
10
Registered
2014-08-26
Start date
2014-06-02
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 : Target:male who has no medical problem. Method:after intake the Herbal medication, compute the density of component indicators in blood. Phellodendri Cortex: get blood samples 12 times durin

Sponsors

Jeollanamdo Development Institute of Korean Traditional Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1)Volunteer; age range of 19-55 years, and male who has no medical problem. 2)Body weight over 55Kg and IBW ranging from +-20%.(IBW: {height(cm)-100}*0.9) 3)with no congenital or chronical diseases and internal medical examination result including ECG is clear. 4)suitable at clinical pathology examination including blood test, urin test.

Exclusion criteria

Exclusion criteria: 1)anyone who has liver, kidney, nervous system, respiratory system, immune system, musculoskeletal system, endocrine system diseases, or mental disorder and who has past history(hepatitis B, C). Especially galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. 2)anyone who has gastro-intestinal diseases(Chron's disease, ulcer, acute or chronic pancreatitis) and gastro-intestinal surgery(without appendectomy, hernitomy). 3)After 3min rest : -systolic blood pressure: =90mmHg or =160mmHg. -diastolic blood pressure: =60mmHg or =100mmHg. 4)average drinking quantity: Alcohol 30g/day or cannot stop drinking during this clinical test. 5)Anyone who takes beverage containing Xanthine 4 cups a day or more. 6)Anyone who smokes more than 20 cigarrettes or who can not stop smoking during blood gathering periods. 7)Anyone who has taken drug like barbiturates or has taken lots of Alcohol. 8)Anyone who has past history about drug abuse or who has possibility about misusing and abusing through physical checkup(Amphetamine, babiturates, cocaine, opioids, benzodia zepines and so on) 9)Volunteer who has taken herbal medicine within 30 days. Volunteer who has taken professional medicine within 14days. anyone who has taken general medicine within 10 days. 10)Volunteer who has been in Bioequivalence test or clinical demonstration within 90 days. 11)Volunteer who can not eat typical meal provided by Suncheon Dongshin university hospital. 12)Volunteer who judged incongruent by tester through clinical examination center.

Design outcomes

Primary

MeasureTime frame
Measured density of component indicator in extracted plasma at sampling time. And compute the area of under the “density of component indicator in blood - time“ curve. Phellodendri Cortex

Countries

Korea, Republic of

Contacts

Public ContactSeung Yang

Dongshin University Suncheon Oriental Hospital

cigipus@hanmail.net+82-61-729-7199

Outcome results

None listed

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