Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mg

This study has been completed.
Sponsor:
Information provided by:
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00934323
First received: July 6, 2009
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

The pharmacokinetics of glimepiride and metformin will be compared after single dose intake of both combinations in order to answer to the following questions:

  • Is there a dose proportionality effect between Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?
  • What is the safety profile of Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?

Condition Intervention Phase
Healthy
Drug: Amaryl M SR 1/500 mg
Drug: Amaryl M SR 2/500 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open, Randomized, Two-Treatment, Crossover Study to Assess the Dose Proportionality of Glimepiride Between Amaryl M SR 1/500mg and 2/500mg (Glimepiride-Metformin Fixed Dose Combination Tablet) in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • AUClast/D, Cmax/D [ Time Frame: pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax, T1/2 [ Time Frame: pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration ] [ Designated as safety issue: No ]
  • Vital signs, ECG, physical examination, clinical laboratory tests [ Time Frame: screening, treatment period 1 & 2, Post-study visit ] [ Designated as safety issue: Yes ]
  • Adverse Event [ Time Frame: Treatment period 1 & 2, Post-study visit ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TR sequential group
Amaryl M SR 1/500 mg in period 1 and Amaryl M SR 2/500 mg in period 2
Drug: Amaryl M SR 1/500 mg
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group
Other Name: Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mg
Drug: Amaryl M SR 2/500 mg
single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group
Other Name: Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mg
Active Comparator: RT sequential group
Amaryl M SR 2/500 mg in period 1 and Amaryl M SR 1/500 mg in period 2
Drug: Amaryl M SR 1/500 mg
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group
Other Name: Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mg
Drug: Amaryl M SR 2/500 mg
single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group
Other Name: Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mg

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: Between 20 to 45 years of age, inclusive (Age based on the date to give the informed consent)
  • Ideal body weight (Broca index): between 50 to 90 kg, inclusive, and within ±20 % of Ideal Body Weight, [(Height in cm-100)×0.9]
  • Subjects who are appropriate to participate in this study judged from clinical laboratory and physical examinations taken within 4weeks prior to the start of study
  • Subjects who are able to abstain from caffein or caffein-containing products (e.g., coffee, cola, tea, chocolate), grapefruit and grapefruit containing products, alcohol and smoking within 72 hours before dosing and during the hospitalization
  • Subjects who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

  • History of allergies including drug allergy, except untreated, asymptomatic, seasonal allergies at the time of dosing
  • Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 10 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (If used medication is considered acceptable by investigator, patients can be included)
  • History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
  • History of a significant surgical resection of gastrointestinal tract except appendectomy
  • Abnormal clinical laboratory findings, especially for AST or ALT> 1.25 fold of upper normal limit
  • Evidence of alcohol abuse (defined as regular alcohol intake that exceeds 24 oz [675 ml] of beer, 12 oz [340 ml] of wine or 160 ml of soju or 3 oz [85 ml] hard liquor [e.g., brandy, whiskey, gin] per day) or drug abuse
  • Heavy smokers (> 10 cigarettes per day), or can't quit smoking during hospitalization
  • Participation in clinical trials of any drug within 3 months prior to the participation of the study
  • Donation of whole blood within 2 months or a unit of blood within 1 month prior to the start of study [Day 1].
  • Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or HIV antibody
  • Judged to be inappropriate for the study by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934323

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Principal Investigator: In-Jin Jang, Professor Seoul National University Hospital
  More Information

No publications provided by Handok Pharmaceuticals Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hye Jin Cheong/ Head of Clinical Research Operation, Handok Pharmaceuticals, Co., Ltd
ClinicalTrials.gov Identifier: NCT00934323     History of Changes
Other Study ID Numbers: M_SR_001
Study First Received: July 6, 2009
Last Updated: July 7, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Handok Pharmaceuticals Co., Ltd.:
volunteer

Additional relevant MeSH terms:
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 16, 2014