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

This study has been completed.
Sponsor:
Information provided by:
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00934817
First received: July 6, 2009
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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?

Condition Intervention Phase
Healthy
Drug: Amaryl-M 2/500 mg
Drug: Amaryl-M 1/500 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 1mg/500mg and 2mg/500mg (Glimepiride-Metformin Fixed Dose Combination Tablet) in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Plasma drug concentrations of glimepiride and metformin, PK parameters: AUCt, AUCinf, Cmax, Tmax, T1/2 [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical examination, clinical laboratory tests [ Time Frame: Screening, 2 day, 9 day, 13-15 day ] [ Designated as safety issue: Yes ]
  • Vital sign [ Time Frame: screening, 1 day, 2 day, 8 day, 9 day, 13-15 day ] [ Designated as safety issue: Yes ]
  • Adverse event [ Time Frame: 1 day, 2 day, 8 day, 9 day, 13-15 day ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: March 2007
Study Completion Date: August 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TR sequential group
Amaryl-M 1/500 mg in period 1, Amaryl-M 2/500 mg in period 2
Drug: Amaryl-M 2/500 mg
single oral administration in period 2 for TR sequential group, and in period 1 for RT sequential group, respectively
Other Name: glimepiride 2 mg & metformin HCl 500 mg
Drug: Amaryl-M 1/500 mg
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively
Other Name: glimepiride 1 mg & metformin HCl 500 mg
Active Comparator: RT sequential group
Amaryl-M 2/500 mg in period 1, Amaryl-M 1/500 mg in period 2
Drug: Amaryl-M 2/500 mg
single oral administration in period 2 for TR sequential group, and in period 1 for RT sequential group, respectively
Other Name: glimepiride 2 mg & metformin HCl 500 mg
Drug: Amaryl-M 1/500 mg
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively
Other Name: glimepiride 1 mg & metformin HCl 500 mg

Detailed Description:

16 subjects were randomized to each of 2 sequence groups which have different treatment order of the study drug in each period.

Only healthy volunteers had screening tests such as medical inquiry, physical examination, clinical laboratory test, etc. within 4 weeks (-28d ~ -1d) prior to drug administration (1d) and those determined eligible for this study were selected and randomized between screening and 1 day prior to the first administration of study medication (-1d). Then, the subjects were admitted to the clinical research center of Seoul National University Hospital by 9 p.m. of -1d and then, they were not allowed to take anything except water.

After one week of washout period, subjects went on to the second phase of treatment period and were administered according to the treatment order in a crossover way. For the subjects who completed the study, post-study visit tests were performed after a designated time had passed.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT00934817

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

No publications provided

Responsible Party: Hye Jin Cheong / Head of Clinical Research Operation, Handok Pharmaceuticals, Co., Ltd
ClinicalTrials.gov Identifier: NCT00934817     History of Changes
Other Study ID Numbers: GLIME_L_02279
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