Relative bioavailability study of two candidate formulations of GR107719B (Mosapride 5 mg) under fasting conditions
- Registration Number
- CTRI/2014/01/004318
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GSK Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
Body weight >= 50 kg and BMI within the range 19 â?? 24.9 kg/m2 (inclusive)
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until the follow-up contact visit
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
ALT, alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period QTcF < 450 msec
Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterise the relative bioavailability of mosapride following administration of two candidate tablet formulations of mosapride citrate (GR107719B; 5mg) relative to reference mosapride citrate (Gasmotin; 5mg) in healthy human subjects under fasting conditions. <br/ ><br>Plasma PK parameters including Cmax, AUC(0-â??) and AUC(0-t) for mosapride citrate in relevant treatmentsTimepoint: Seventeen (17) blood samples (1 x 5 mL) will be collected in pre-labelled K2EDTA vacutainers, during each period. Single venous blood sample will be withdrawn at pre-dose (0.00) and at 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose
- Secondary Outcome Measures
Name Time Method To characterise secondary PK parameters of two candidate tablet formulations of mosapride citrate (GR107719B; 5mg) relative to reference mosapride citrate tablets (Gasmotin; 5mg) in healthy human subjects under fasting conditions. <br/ ><br>Plasma PK parameters: tmax, %AUCex and t½ <br/ ><br>Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements, review of adverse events and clinical laboratory safety dataTimepoint: Seventeen (17) blood samples (1 x 5 mL) will be collected in pre-labelled K2EDTA vacutainers, during each period. Single venous blood sample will be withdrawn at pre-dose (0.00) and at 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose