A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects
This study has been completed.
Sponsor:
CJ Cheiljedang Corporation
Information provided by (Responsible Party):
CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier:
NCT01039896
First received: December 23, 2009
Last updated: February 11, 2013
Last verified: February 2013
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Purpose
The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807 Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open-label, Randomized, Crossover Study to Evaluate the Safety and Pharmacokinetics After Multiple Administration of SLM0807 Alone and Multiple Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by CJ Cheiljedang Corporation:
Primary Outcome Measures:
- Css,max and AUCinf [ Time Frame: up to 24hrs ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- AUCtau, AUCt, Tmax [ Time Frame: up to 24hrs ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | June 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group1
SLM0807
|
Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807 |
|
Experimental: Group2
SLM0807 and HKB0701
|
Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807 |
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
- Subjects with no history of any significant chronic disease
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
- Available for the entire study period
- Willing to adhere to protocol requirements and sign a informed consent form.
Exclusion Criteria:
- Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
- Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
- Subjects with a history of clinically significant allergies including drug allergies
- Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.25 times to normal range or total bilirubin > 1.5times to normal range)
- Subjects with a history of drug, caffeine or alcohol abuse (caffeine drink >5cups /day, alcohol >30g/day)
- Heavy smoker ( >10cigarettes/day)
- Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
- Subjects who have donated plasma within 60days prior to drug administration
- Subjects who have participated in a clinical study within 90days prior to drug administration
- Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator (cimetidine within 7days prior to drug administration)
- Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
Contacts and Locations
More Information
No publications provided
| Responsible Party: | CJ Cheiljedang Corporation |
| ClinicalTrials.gov Identifier: | NCT01039896 History of Changes |
| Other Study ID Numbers: | CJ_VCM_101 |
| Study First Received: | December 23, 2009 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013