Cinical trial of the safety and pharmacokinetic characteristics between TuNEX 25 mg and Enbrel 25 mg subcutaneous injections in healthy male volunteers

A randomized, open-label, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of TuNEX injection 25 mg with those of Enbrel injection 25 mg after subcutaneous injection in healthy male volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000118

Enrollment

Registered

2011-05-25

Start date

2008-11-07

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 : Single subcutaneous injection of TuNEX 25 mg or Enbrel 25 mg

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy male adults aged 20 ~ 55 at screening 2. No clinically significant congenital or chronic disease (if required, encephalography, electrocardiogram, thoracic or gastroendoscope or gastroradiography) or pathological symptoms 3. Judged to be healthy by the responsible doctor based on clinical laboratory test results such as a general blood test, serochemical test and urine test, etc. 4. Signed informed consent 5. Able to participate during the study period and conform to the study requirements

Exclusion criteria

Exclusion criteria: 1. Past or current medical history for the diseases in hepatobiliary, renal, nervous, hematologic or cardiovascular systems including oncologic diseases. 2. Clinically significant history or current hypersensitivity to pharmaceutical containing an ingredient of the test or reference drugor other relevant pharmaceuticals (aspirin, antibiotics, etc.) 3. Either a “systolic B.P. = 90 mmHg or diastolic B.P. = 50 mmHg” or “systolic B.P. = 150 mmHg or diastolic B.P. = 100 mmHg” at measurement in the sitting position after over 3 min rest. 4. Septicemia or the risk of it 5. Active infection (chronic or local) including tuberculosis 6. A history of drug abuse or a positive result on urine drug testing 7. Used any drug metabolic enzyme inducer or inhibitior such as barbituates or drank excessive alcohol within 1 month prior to study initiation 8. Administered any prescription drug or herbal medicine within 2 weeks prior to the first administration day, or administered any over-the-counter drug or vitamin agent within 1 week before the first administration (however, such a subject can be included when investigators so determined after considering other conditions) 9. Participated in another clinical study within 2 months prior to first administration 10. Donated whole blood within 2 months prior to the first administration, apheresis within 1 month prior to the first administration or treated with transfusion within 1 month prior to first administration 11. Chronic alcohol consumer (over 21 units/week, 1 unit = 10 g of pure alcohol) or inable to stop drinking during the study 12. Determined to be inappropriate for the study based on laboratory tests or other reasons

Design outcomes

Primary

Measure	Time frame
Adverse events (AE), vital signs (VS), 12-lead electrocardiograms (ECG), physical examination (PE), clinical laboratory test	—

Secondary

Measure	Time frame
Serum concentration-time profile of etanercept, pharmakinetic parameters (Cmax, Tmax, AUC, half-life)	—

Countries

Korea, Republic of

Contacts

Public ContactNamyi Gu

Seoul National University Hospital

Outcome results