AzTrials
AzTrials

Healthy SubjectsPhase 1NCT00549263

Bioequivalence Study of SB797620 in Healthy Japanese Volunteers

A Phase 1 study testing SB797620 in people with Healthy Subjects, run by GlaxoSmithKline.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This study will test whether the Drug levels in plasma after combination formulation tablet dosing (SB797620) and separate formulation tablets dosing (rosiglitazone and glimepiride) to Japanese Healthy volunteer would be the same or not. Read more about this study

Who is it for?
Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
SB797620
How many people
0 participants
Where
No sites listed yet
Study dates
Feb 2008to not given
Phase
Phase 1
Are there results?
None posted in the registry

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 20 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects
  • They are Japanese males.
  • Aged 20 to 55 years, inclusive.
  • They have body mass index at screening within 18.5-25.0. Body weight 50-80kg.
  • AST(GOT), ALT(GPT), gumma-GPT and ALP: below the upper normal range
  • They are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • They could refrain from smoking during hospitalization.
  • They are able to attend all visits and complete the study.

Who cannot join

  • The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
  • Known hepatic or biliary abnormalities such as Gilbert's syndrome.
  • Use of insulin or oral anti-hyperglycemic agents within the past 3 months prior to screening.
  • Subjects who have a history of lactose intolerance.
  • The subject has an allergy for any drug or idiosyncrasy. This excludes a pollen allergy without current symptoms.
  • The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
Show all 19Show fewer
  • The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
  • The subject has a screening ECG with a QTc value outside the range 320 to 450msec, a PR interval of >230msec and/or a QRS interval of >120msec.
  • The subject has a heart rate outside the range 40 to 110 bpm at screening.
  • The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" within the previous 1 month.
  • The subject is currently taking regular (or a course of) medication (including prescribed drug, over-the-counter medication and herbal remedies), and can not cease them 30 days prior to th first study drug dosing.
  • The subject has a history or current conditions of drug abuse or alcoholism.
  • History of alcohol consumption in the past six months exceeding 7 drinks per week (where 1 drink is 350mL in terms of beer)
  • The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, HTLV-1 antibody.
  • The subject is positive for urine drug screening.
  • Current history of hypo- or hyperglycemia as indicated by serum glucose values below the laboratory-specified reference range or =110 mg/dL, at screening, or as reported by the subject.
  • History of surgical procedures that might affect the absorption of RSG or GLIM (e.g., partial/total gastrectomy, cholecystectomy).
  • History of hypersensitivity to thiazolidinediones, sulfonylureas or compounds with similar chemical structures.
  • History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof.

About this study

Official title: A Bioequivalence Study With a Combination Tablet Formulation of Rosiglitazone (RSG) and Glimepiride (GLIM)(4mg/2mg) Compared to Concomitant Dosing of RSG 4mg Tablet and GLIM 1mg Commercial Tablet x 2 (4mg+2mg) in Japanese Healthy Male Subjects

This study will test whether the Drug levels in plasma after combination formulation tablet dosing (SB797620) and separate formulation tablets dosing (rosiglitazone and glimepiride) to Japanese Healthy volunteer would be the same or not.

Being tested
SB797620
Keywords
Safety, Pharmacokinetics, Bioequivalence

What participants receive

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

  • SB797620Drug

What is being measured

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

  1. Drug levels on Day 1

    Measured: Day 1

Secondary outcomes (3)

  1. Adverse events on Day 1

    Measured: Day 1

  2. Clinical laboratory test on Day 1

    Measured: Day 1

  3. Vital signs and 12-lead ECG on Day 1

    Measured: Day 1

Timeline

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

  1. First posted25 Oct 2007 (estimated)
  2. Study startFeb 2008

Why it stopped: No subjects enrolled, bio equivalence study, canceled before active.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00549263
Sponsor's protocol ID
AVR110549
Status last verified
Feb 2015
First submitted
23 Oct 2007
Last updated
23 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB797620 in people with Healthy Subjects, run by GlaxoSmithKline.

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 8 inclusion and 19 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: withdrawn, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Drug levels on Day 1 (time frame: Day 1). 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 NCT00549263.

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 23 Feb 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in