Pharmacokinetic study of fermented red ginseng extract

A single dose, open study in healthy male volunteers to evaluate the pharmacokinetics and the safety of fermented red ginseng extract

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000735

Enrollment

Registered

2013-04-29

Start date

2011-10-14

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

Dietary Supplement : fermented red ginseng extract 5g PO once

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy male subjects between the ages of 20 and 55 years 2. An informed consent document signed and dated by the subject.

Exclusion criteria

Exclusion criteria: 1. Evidence or a history of clinically significant hepatic, pancreas, renal, neurological, pulmonary, endocrine, hematological, psychiatric, cardiovascular disease 2. Any disease or history possibly affecting drug absorption (e.g. chohn's disease, gastrectomy). 3. ginseng-associated hypersensitivity history 4. systolic blood pressure (SBP) = 150 mmHg or =100 mmHg or diastolic blood pressure (DBP) = 95 mmHg or = 65 mmHg 5. received any antibiotics within 4 weeks or any ginseng contained herbal medicines within 1 weeks before the study

Design outcomes

Primary

Measure	Time frame
Cmax;AUClast;AUCinf	—

Secondary

Measure	Time frame
Clearance;Volume of distribution;half-life	—

Countries

Korea, Republic of

Contacts

Public ContactMin-Gul Kim

Chonbuk National University Hospital

mgkim@jbnu.ac.kr+82-63-250-1487

Outcome results