Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg

NCT00934817 | Completed Phase 1

• 1 other identifier: GLIME_L_02279
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

• Is Amaryl-M 1/500 mg (Test tablet) proportional to Amaryl-M 2/500 mg tablet with regard to the glimepiride component?
• Is Amaryl-M 1/500 mg (Test tablet) tolerable comparing with Amaryl-M 2/500 mg?

Conditions

Healthy

Keywords

Volunteer

Outcome Measures

Primary Outcomes (1)

• Plasma drug concentrations of glimepiride and metformin, PK parameters: AUCt, AUCinf, Cmax, Tmax, T1/2

  pre-dose (= 1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 30 hrs after drug administration

Secondary Outcomes (3)

• Physical examination, clinical laboratory tests

  Screening, 2 day, 9 day, 13-15 day

• Vital sign

  screening, 1 day, 2 day, 8 day, 9 day, 13-15 day

• Adverse event

  1 day, 2 day, 8 day, 9 day, 13-15 day

Study Arms (2)

TR sequential group

EXPERIMENTAL

Amaryl-M 1/500 mg in period 1, Amaryl-M 2/500 mg in period 2

Drug: Amaryl-M 2/500 mg; Drug: Amaryl-M 1/500 mg

RT sequential group

ACTIVE COMPARATOR

Amaryl-M 2/500 mg in period 1, Amaryl-M 1/500 mg in period 2

Drug: Amaryl-M 2/500 mg; Drug: Amaryl-M 1/500 mg

Interventions

Amaryl-M 2/500 mg DRUG

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

Also known as: glimepiride 2 mg & metformin HCl 500 mg

RT sequential group; TR sequential group

Amaryl-M 1/500 mg DRUG

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

Also known as: glimepiride 1 mg & metformin HCl 500 mg

RT sequential group; TR sequential group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: Between 19 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 caffeine or caffeine-containing products (e.g., coffee, cola, tea, chocolate), grapefruit and grapefruit containing products, alcohol and smoking within 7 days before dosing and during the hospitalization
• Subjects who give their informed consent voluntarily to participate in the study

You may not qualify if:

• History of allergies including drug allergy, except untreated, asymptomatic, seasonal allergies at the time of dosing
• Use any medication not considered acceptable by the clinical investigator during the last 10 days period before the start day of the study
• Use of any inducer or inhibitors of metabolizing enzymes during the last 28 days before the start day of the study.
• 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, total bilirubin \> 1.5 fold of upper normal level
• Pregnant or lactating woman or woman of childbearing potential without medically acceptable birth control during the study
• 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 per day \[e.g., brandy, whiskey, gin\]) 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 start of study
• Donation of 200ml of whole blood within 4 weeks or 400ml within 12 weeks prior to the start of study
• 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

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: March 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: August 1, 2007
• Last Updated: July 8, 2009

Record last verified: 2009-07