Drug-drug Interaction Study (CKD-501, Ketoconazole)
This study has been completed.
Sponsor:
Chong Kun Dang Pharmaceutical
Collaborator:
Severance Hospital
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01330563
First received: April 5, 2011
Last updated: June 28, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: CKD-501, Ketoconazole |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Drug-Drug Interaction Study to Investigate the Effect of Ketoconazole on the Pharmacokinetic Properties of CKD-501 in Healthy Male Volunteer: Open, Randomised, 2-way Crossover, Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Chong Kun Dang Pharmaceutical:
Primary Outcome Measures:
- CKD-501 AUC [ Time Frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CKD-501 Cmax [ Time Frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr ] [ Designated as safety issue: No ]
- CKD-501 Tmax [ Time Frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | March 2011 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CKD-501
Subjects received Ketoconazole 200 mg twice daily for 5 days in one period and in the other period, Subjects don't receive Ketoconazole. In addition, The CKD-501 is administered on day 5 |
Drug: CKD-501, Ketoconazole
Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.
Other Name: Lobeglitazone, Ketoconazole
|
|
Experimental: ketoconazole
Subjects received Ketoconazole 200 mg twice daily for 5 days in one period and in the other period, Subjects don't receive Ketoconazole. In addition, The CKD-501 is administered on day 5 |
Drug: CKD-501, Ketoconazole
Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.
Other Name: Lobeglitazone, Ketoconazole
|
Detailed Description:
From day 1 to day 5, Ketoconazole 200mg is administered twice daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg is co-administered Group 1 patients at period 1. After 28 day-break, period 2 will CKD-501 0.5mg administered on day 5. Period 2 will not Ketoconazole administered.
Group 2 is administered in reverse order.
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Between 20 aged and 45 years old in healthy males
- 18.5 ≤ IBW < 25
- Agreement with written informed consent
Exclusion Criteria:
- Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
- Medication with drug-mediated induction/inhibition metabolic enzyme such as Midazolam within 1 month or with may affect the clinical trial
- Subject has taken abnormal meals which affects the ADME of drug
- Subject has a history(such as gastric or duodenal ulcer, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
- Substance abuse, or a history of drug abuse showed a positive for the party
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
- Previously participated in other trial within 60 days
- Previously donate whole blood within 60 days or component blood within 30 days
- Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
- SBP >140 mmHg, SBP < 90 mmHg or DBP > 90 mmHg, DBP < 50 mmHg or Pulse > 100 per/min, Pulse < 50 per/min
- 12-lead ECG, QTc > 450 msec
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330563
Locations
| Korea, Republic of | |
| Severance Hospital | |
| Seoul, Korea, Republic of, 120-752 | |
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Severance Hospital
Investigators
| Principal Investigator: | Minsoo Park | Severance Hospital |
More Information
No publications provided
| Responsible Party: | Chong Kun Dang Pharmaceutical, Chin Kim |
| ClinicalTrials.gov Identifier: | NCT01330563 History of Changes |
| Other Study ID Numbers: | 19HPS11G |
| Study First Received: | April 5, 2011 |
| Last Updated: | June 28, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Chong Kun Dang Pharmaceutical:
|
Drug-Drug interaction between the CKD-501 and ketoconazole |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Ketoconazole 14-alpha Demethylase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013