Bioequivalence and Food Effect Study in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 2, 2007

Primary Completion Date

September 26, 2007

Study Completion Date

September 26, 2007

Conditions
Sleep Initiation and Maintenance Disorders
Interventions
DRUG

Formulation A

Formulation A represents the original formulation. SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing micronized drug substance. Formulation A will be administered in Part A.

DRUG

Formulation B

Formulation B will represent SB-649868 10 mg film coated tablet containing micronized drug substance (3 tablets to reach 30 mg), but contains additional surfactant. Formulation B will be administered in Part A.

DRUG

Formulation C

Formulation C will represent SB-649868 10 mg lipophilic capsule (3 capsules to reach 30 mg). Formulation C will be administered in Part A.

DRUG

Formulation D

Formulation D will represent SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing nanomilled and spray dried powder. Formulation D will be administered in Part A.

DRUG

Formulation E

Formulation E will represent SB-649868 10 mg capsule (3 capsules to reach 30 mg), containing nanomilled and spray dried powder. Formulation E will be administered in Part A.

DRUG

Formulation F

Formulation F will represent SB-649868 15 mg liquid filled capsule (2 capsules to reach 30 mg). Formulation F will be administered in Part A.

DRUG

Formulation G

Formulation G will be the selected formulation of SB-649868 30 mg to be assessed in Part B. The formulation will be administered after a standard FDA High-Fat breakfast

Trial Locations (1)

37134

GSK Investigational Site, Verona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY