Diabetes Mellitus, Type 2Phase 1NCT01332071

Avandamet Bioequivalence Study Brazil - Fed Administration

A Phase 1 study testing Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg and Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg and Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteBrazil
Study dates: 24 Nov 2009to 6 Dec 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

GSK Investigational Site
Goiânia, Goiás

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Conditions: Diabetes Mellitus, Type 2
Being tested: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg, Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Keywords: Metformin, Rosiglitazone, Healthy volunteers, Avandamet, Fed conditions, Bioequivalence
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mgDrug
Avandamet reference product
Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mgDrug
Avandamet test product

Study groups in NCT01332071
Study group	Role	What they receive
Avandamet test product	Active comparator	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 Receives: Drug: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Avandamet reference product	Active comparator	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 Receives: Drug: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0-t of Rosiglitazone Maleate
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.
Measured: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
Cmax of Rosiglitazone Maleate
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.
Measured: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
AUC0-infinity of Rosiglitazone Maleate
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.
Measured: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
AUC0-t of Metformin Hydrochloride
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.
Measured: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
AUC0-infinity of Metformin Hydrochloride
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.
Measured: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
Cmax of Metformin Hydrochloride
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.
Measured: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 20096 Dec 2009

First posted8 Apr 2011 (estimated)
Study start24 Nov 2009
Primary completion6 Dec 2009
Study completion6 Dec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01332071
Sponsor's protocol ID: 114040
Status last verified: Jun 2017
First submitted: 31 Aug 2010
Last updated: 12 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT01332071
Acronym / sponsor ID: 114040
Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin, Rosiglitazone, Healthy volunteers, Avandamet, Fed conditions, Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 24 Nov 2009 (actual)
Primary completion: 6 Dec 2009 (actual)
Study completion: 6 Dec 2009 (actual)
First posted: 8 Apr 2011 (estimated)
Results: Posted 8 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Avandamet test product	Active comparator	Drug: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mgTest 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 reference product	Active comparator	Drug: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mgReference 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

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mgAvandamet reference product	Drug	Avandamet reference product
Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mgAvandamet test product	Drug	Avandamet test product

Primary outcome

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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 8 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product in Period 1; Reference Product in Period 2	13	13
Reference Product in Period 1; Test Product in Period 2	13	13

Primary outcome: 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). Mean (Standard Deviation). Unit: ng per hour per ml (ng.h/ml)

Measure	Test Product n = 26	Reference Product n = 26
Value	1731.22 (510.47)	1770.93 (469.14)

Test Product vs Reference Product: Ratio T formulation/R formulation: 96.58 (90% CI 93.44 to 99.83)

Population analysed: Participants who completed the study

Primary outcome: 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). Mean (Standard Deviation). Unit: ng/ml

Measure	Test Product n = 26	Reference Product n = 26
Value	265.45 (44.33)	270.97 (48.32)

Test Product vs Reference Product: Ratio T formulation/R formulation: 97.76 (90% CI 93.25 to 102.50)

Population analysed: Participants who completed the study

Primary outcome: 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). Mean (Standard Deviation). Unit: ng.h/ml

Measure	Test Product n = 26	Reference Product n = 26
Value	1776.28 (519.63)	1825.35 (494.35)

Test Product vs Reference Product: Ratio T formulation/R formulation: 96.47 (90% CI 93.32 to 99.72)

Population analysed: Participants who completed the study

Primary outcome: 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). Mean (Standard Deviation). Unit: ng.h/ml

Measure	Test Product n = 26	Reference Product n = 26
Value	9623.4 (2175.4)	10074.4 (2411.7)

Test Product vs Reference Product: Ratio T formulation/R formulation: 95.79 (90% CI 91.67 to 100.10)

Population analysed: Participants who completed the study

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product in Period 1; Reference Product in Period 2	0 of 13 (0%)	13 of 13 (100%)	Not reported
Reference Product in Period 1; Test Product in Period 2	0 of 13 (0%)	13 of 13 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results for study 114040 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01332071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.