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

NCT00934323 | Completed Phase 1

• 1 other identifier: M_SR_001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Healthy

Keywords

volunteer

Outcome Measures

Primary Outcomes (1)

• AUClast/D, Cmax/D

  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

Secondary Outcomes (3)

• Tmax, T1/2

  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

• Vital signs, ECG, physical examination, clinical laboratory tests

  screening, treatment period 1 & 2, Post-study visit

• Adverse Event

  Treatment period 1 & 2, Post-study visit

Study Arms (2)

TR sequential group

EXPERIMENTAL

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; Drug: Amaryl M SR 2/500 mg

RT sequential group

ACTIVE COMPARATOR

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; Drug: Amaryl M SR 2/500 mg

Interventions

Amaryl M SR 1/500 mg DRUG

single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group

Also known as: Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mg

RT sequential group; TR sequential group

Amaryl M SR 2/500 mg DRUG

single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group

Also known as: Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mg

RT sequential group; TR sequential group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Shin KH, Kim SE, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. Pharmacokinetic comparison of a new sustained-release formulation of glimepiride/metformin 1/500 mg combination tablet and a sustained-release formulation of glimepiride/metformin 2/500 mg combination tablet in healthy Korean male volunteers: a randomized, 2-sequence, 2-period, 2-treatment crossover study. Clin Ther. 2011 Nov;33(11):1809-18. doi: 10.1016/j.clinthera.2011.10.003. Epub 2011 Oct 27.

  PMID: 22036245 DERIVED

MeSH Terms

Interventions

glimepiride; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• In-Jin Jang, Professor

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: April 1, 2009
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

KR (1)