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Clinical trial to evaluate the influence of 6 day-dexamethasone (inducer of CES1)

Clinical trial to evaluate the influence of 6 day-dexamethasone (inducer of CES1) co-administration on the pharmacokinetics of oseltamivir in healthy volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0001533
Enrollment
20
Registered
2015-06-23
Start date
2014-10-03
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 : After the administration of Oseltamivir 75 mg capsule, three tablets of Dexamethasone 0.5 mg tablet were administered repeatedly for six days

Sponsors

Bundang CHA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Subjects who listened to the description about characteristics of this clinical trial and signed the IRB approved consent form before the whole screening tests 2) Healthy Korean male volunteers who are 20 to 45 years old

Exclusion criteria

Exclusion criteria: 1) Subject who have clinical evidence of significant respiratory, cardiological, nephrological, gastrointestinal, endocrinological, hematological, neurological (included ataxia), psychiatric disorders or other chronic disorders, alcohol or substance addiction 2) Subjects who take medicine which is known to have significant drug interaction or is judged as inappropriate by researcher within 14 days of administration of drugs for clinical trial 3) Subjects who donated blood within 30 days from the start of clinical trial or who participated in the clinical trial of other drugs for clinical trials or post marketing surveillance. 4) Subjects who have experienced significant adverse reactions such as hypersensitivity to drugs for clinical trials 5) Subjects who planned pregnancy or cannot use established contraceptions (e.g. infertility operation of the subject or partner, intrauterine contraceptive device of the partner, barrier contraception, diaphragm or condom use in combination during the test 6) Female subject who were pregnant or breast-feeding 7) Subject who are judged as inappropriate for participating in the clinical trial by researcher because of causes including the test result of clinical laboratory

Design outcomes

Primary

MeasureTime frame
Cmax, AUClast, AUCinf, CL/F, CLR/F, t1/2, metabolic ratio

Countries

Korea, Republic of

Contacts

Public ContactMin-Kyoung Kim

Bundang CHA General Hospital

mkkim0212@gmail.com+82-31-780-6255

Outcome results

None listed

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