Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma
Overview[ - collapse ][ - ]
| Purpose | The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in Healthy Male Korean Subjects |
|---|---|
| Condition | Asthma and Allergic Rhinitis |
| Intervention | Drug: Montelukast Drug: Montelukast sodium |
| Phase | Phase 1 |
| Sponsor | PharmaKing |
| Responsible Party | PharmaKing |
| ClinicalTrials.gov Identifier | NCT02029313 |
| First Received | November 3, 2013 |
| Last Updated | January 6, 2014 |
| Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 3, 2013 |
|---|---|
| Last Updated Date | January 6, 2014 |
| Start Date | November 2013 |
| Estimated Primary Completion Date | March 2014 |
| Current Primary Outcome Measures | Number of participants with Adverse event [Time Frame: 1day] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Pharmacokinetic profiles [Time Frame: 1day] [Designated as safety issue: No]Blood evaluation variables: Cmax, AUCt (t=24 h), AUC∞, tmax |
Descriptive Information[ + expand ][ + ]
| Brief Title | Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma |
|---|---|
| Official Title | A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium) Tablet 10mg in Healthy Male Korean Subjects |
| Brief Summary | The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in Healthy Male Korean Subjects |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label |
| Condition | Asthma and Allergic Rhinitis |
| Intervention | Drug: Montelukast Drug: Montelukast sodium |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 40 |
| Estimated Completion Date | March 2014 |
| Estimated Primary Completion Date | January 2014 |
| Eligibility Criteria | Inclusion Criteria: - Healthy Korean Male over20, under 45 years old - 55kg over weight, IBW +-20% range male Exclusion Criteria: - Males who have gotten a clinically significant of liver, pancreas, kidneys, nervous system, respiratory system, endocrine system, blood cancer, mental illness, cardiovascular, urinary tract disease, or a history corresponding - Males who have gotten a history of gastrointestinal disease - Males who have gotten a history of hypersensitivity to montelukast or reaction to other drugs(aspirin, antibiotics) |
| Gender | Male |
| Ages | 20 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Contact: Soohyun Lee 82-2-6925-4068 isulala@naver.com |
| Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02029313 |
|---|---|
| Other Study ID Numbers | PMK-M01RS1 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | PharmaKing |
| Study Sponsor | PharmaKing |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | January 2014 |
Locations[ + expand ][ + ]
| Inha University Hospital | Incheon, Junggu, Korea, Republic of Contact: Sangheon Cho | 82-32-890-1122 | shcho123@inha.ac.krRecruiting |
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