Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers
This study is currently recruiting participants.
Verified September 2011 by Hanwha Chemical
Sponsor:
Hanwha Chemical
Information provided by (Responsible Party):
Hanwha Chemical
ClinicalTrials.gov Identifier:
NCT01431404
First received: September 5, 2011
Last updated: September 8, 2011
Last verified: September 2011
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Purpose
The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection in healthy male volunteers.
Pharmacokinetics Time Frame: 0 h(pre-dose), 3, 6, 12, 24, 36, 48, 60, 72, 96, 144, 216, 312, 480 h post-dose-dose Description: AUClast, AUCinf, Cmax, Tmax, t1/2, CL/F
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: Etanercept (Enbrel) Biological: HD203 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized,Double-blind,Single-dosing,Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 Liquid 25 mg With Those of Enbrel Prefilled® Injection |
Resource links provided by NLM:
Further study details as provided by Hanwha Chemical:
Primary Outcome Measures:
- Composite of Pharmacokinetics [ Time Frame: 0 h(pre-dose), 3, 6, 12, 24, 36, 48, 60, 72, 96, 144, 216, 312, 480 h post-dose ] [ Designated as safety issue: No ]Etanercept Pharmacokinetics: AUClast, AUCinf, Cmax, Tmax, t1/2, CL/F
| Estimated Enrollment: | 44 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Enbrel, prefilled syringe |
Biological: Etanercept (Enbrel)
prefilled syringe, SC
|
| Experimental: HD203, prefilled syringe |
Biological: HD203
HD203, prefilled syringe, SC injection
|
Detailed Description:
A randomized, double-blind, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled® injection 25 mg after subcutaneous injection in healthy male volunteers Pharmacokinetics Time Frame: 0 h(pre-dose), 3, 6, 12, 24, 36, 48, 60, 72, 96, 144, 216, 312, 480 h post-dose-dose Description: AUClast, AUCinf, Cmax, Tmax, t1/2, CL/F
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 20 to 40 years of healthy volunteers
- Weight over 55kg
- Subject who signed on ICF
Exclusion Criteria:
- Subject who had been treated with Etanercept before
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431404
Contacts
| Contact: Jaehong Kim, Mr. | 82 2 729 5344 | jaehongkim@hanwha.co.kr |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. | |
Sponsors and Collaborators
Hanwha Chemical
Investigators
| Principal Investigator: | Kyung-Sang Yu, M.D., Ph.D. | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | Hanwha Chemical |
| ClinicalTrials.gov Identifier: | NCT01431404 History of Changes |
| Other Study ID Numbers: | EAGLE-I-11 |
| Study First Received: | September 5, 2011 |
| Last Updated: | September 8, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
TNFR-Fc fusion protein Immunoglobulin G Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013