Bioequivalence Study of SB797620 in Healthy Japanese Volunteers

NCT00549263 | Withdrawn Phase 1

• 1 other identifier: AVR110549
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Subjects

Keywords

Safety; Pharmacokinetics; Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Drug levels on Day 1

  Day 1

Secondary Outcomes (3)

• Adverse events on Day 1

  Day 1

• Clinical laboratory test on Day 1

  Day 1

• Vital signs and 12-lead ECG on Day 1

  Day 1

Interventions

SB797620 DRUG

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 25, 2007
• Study Start: February 1, 2008
• Last Updated: February 23, 2015

Record last verified: 2015-02