- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01332071
Avandamet Bioequivalence Study Brazil - Fed Administration
June 14, 2017 updated by: GlaxoSmithKline
Assessment of Relative Bioavailability of Avandamet 4 mg + 1000 mg (GSK) in the Form of Film Coated Tablets Versus Avandamet 2 mg + 500 mg (GSK) in the Form of Film Coated Tablets, in Healthy Volunteers After Feeding Standardized, Using Liquid Chromatography.
The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods.
The volunteers received, in each period, the reference or the test formulation after standardized meals.
Study Overview
Status
Completed
Conditions
Detailed Description
This is an open-label, randomized, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy volunteers received, in each period, the test or the reference formulation after standardized meals.
Test product is Rosiglitazone Maleate + Metformin - Avandamet 4 mg + 1000 mg (GlaxoSmithKline Brasil Ltda) in the form of film coated tablets.
Reference product is Rosiglitazone Maleate + Metformin - Avandamet 2 mg + 500 mg (Glaxo Smith Kline Brasil Ltda) in the form of film coated tablets.
The population is composed by 26 healthy volunteers, adults, of both genders and their ages varied between 18 and 50 years.
Their body mass index (BMI) varied between 18,5 and 25.
There are no restrictions regarding the ethnic group.
The relative bioavailability of the two formulations, after oral administration, will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Goiás
-
Goiania, Goiás, Brazil
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
EXCLUSION CRITERIA:
- The volunteer has a known hypersensitivity to the study drug or to compounds chemically related;
- History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug's absorption, distribution, excretion or metabolism;
- History of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic or cardiovascular illness;
- Hypo or hypertension of any etiologic that needs pharmacologic treatment;
- The results of the laboratory exams are out of the values considered as normal according this protocol's rules, unless that they are considered as clinically irrelevant by the investigator;
- Has history of alcohol or drugs abuse;
- History of use drug inducing and/or inhibitors of hepatic metabolism within 30 days prior to drug study administration;
- Use of MAO inhibitors two weeks before the start of treatment; - Use of inhibitors of 5-TH reuptake,
- Pregnancy or breastfeeding,
- Smoking;
- Use of regular medication within 4 weeks prior to study iniciation;
- Use of experimental drug or participation in any clinical study within 6 months prior to study iniciation.
INCLUSION CRITERIA:
- Age between 18 and 50 years;
- Body mass index ≥ 18,5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to 28,75);
- Good health conditions;
- Obtain the Informed Consent's signed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Avandamet test product
Test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 miligrams (mg) + 1000 mg in Period 1, followed by a 7-day washout period during which no medication was administered, followed by reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 mg + 500 mg in Period 2
|
Avandamet test product
|
Active Comparator: Avandamet reference product
Reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 miligrams (mg) + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 mg + 1000 mg in Period 2
|
Avandamet reference product
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-t of Rosiglitazone Maleate
Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
ng, nanograms; ml, milliliter.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Cmax of Rosiglitazone Maleate
Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration.
Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
AUC0-infinity of Rosiglitazone Maleate
Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
AUC0-t of Metformin Hydrochloride
Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
ng, nanograms; ml, milliliter.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
AUC0-infinity of Metformin Hydrochloride
Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Cmax of Metformin Hydrochloride
Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration.
Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 24, 2009
Primary Completion (Actual)
December 6, 2009
Study Completion (Actual)
December 6, 2009
Study Registration Dates
First Submitted
August 31, 2010
First Submitted That Met QC Criteria
March 17, 2011
First Posted (Estimate)
April 8, 2011
Study Record Updates
Last Update Posted (Actual)
July 12, 2017
Last Update Submitted That Met QC Criteria
June 14, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114040
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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