Relative bioavailability study of a new tablet formulation

• Research type

  Research Study

• Full title

  An open label, three treatment , three period, single dose, cross-over, relative bioavailability study of a new tablet formulation containing a fixed dose combination (FDC) of GRC 4039 and GRC 8200 tablets (3+50) mg in healthy, adult volunteers under fasting conditions

• IRAS ID

  118069

• Contact name

  Jim Bush

• Sponsor organisation

  Glenmark

• Eudract number

  2012-004623-21

• ISRCTN Number

  N/A

• Research summary

  This study aims to asses the relative bioavailability of a new fixed dose combination of GRC 4039 and GRC 8200 tablets (3) mg in comparison to GRC 8200 tablets 50 mg and GRC 4039 tablets 3 mg in healthy, adult volunteers under fasting conditions. In this study each participant's scheduled to receive a single oral dose of each study drug in each of the three treatment periods. 30 subjects will be dosed in two groups (Cohort 1 and Cohort 2) of 15 subjects each. Two subjects from Cohort 1 will be dosed at least 48 hrs prior to dosing the rest of subjects in period 1 as a safety precaution. Subjects will initially receive a single dose of the fixed dose combination tablet. Subsequently, after a wash out period of at least 14 days, in the second period all subjects will receive a single oral dose of GRC 8200 tablet. Finally, after a wash out period of at least 5 days following the second period, all subjects will receive a single oral dose of GRC 4039 tablet in the third period. Subjects will attend out patient visits for study procedures during the wash out periods. Healthy male and females will be screened within 28 days of first dose after obtaining written informed consent. Eligible subjects will then be admitted to the Unit two days prior to first dosing for eligibility and safety assessments. They will be dosed in the morning of Day 1 after an overnight fast of at least 10 h and will be discharged after 48 hrs. Subjects will return to the Unit for 2 more study periods in a similar manner and will be resident in the unit from the day before dosing. Total duration of the study is expected to be approximately 8 weeks.

• REC name

  North East - York Research Ethics Committee

• REC reference

  12/NE/0382

• Date of REC Opinion

  14 Nov 2012

• REC opinion

  Favourable Opinion