Clinical trial NCT00549263: Bioequivalence Study of SB797620 in Healthy Japanese Volunteers
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Safety
Pharmacokinetics
Bioequivalence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-25
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Drug levels on Day 1
timeFrame: Day 1
Secondary outcomes:
measure: Adverse events on Day 1
timeFrame: Day 1
measure: Clinical laboratory test on Day 1
timeFrame: Day 1
measure: Vital signs and 12-lead ECG on Day 1
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: