Relative bioavailability study of two candidate tablet formulations of 16mg candesartan cilexetil (GW615775) compared with the reference product Atacand (16mg candesartan cilexetil, AstraZeneca) in healthy human subjects under fasting conditions
- Registration Number
- CTRI/2014/12/005269
- 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 the investigator or medically qualified designee, 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
Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies.
Non-reproductive potential defined as
•Pre-menopausal females with one of the following
•Documented tubal ligation
•Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
•Hysterectomy
•Documented bilateral oophorectomy
•Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause [refer to laboratory reference ranges for confirmatory levels]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment
•Reproductive potential and agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until [at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer] after the last dose of study medication and completion of the follow-up visit
•Hypersensitivity to candesartan cilexetil or to any of the excipients
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the relative bioavailability of candesartan following dministration of two candidate tablet formulations of candesartan cilexetil (GW615775; 16mg) relative to reference candesartan cilexetil tablet (Atacand; 16mg) in healthy human subjects under fasting conditions <br/ ><br> <br/ ><br>Plasma PK parameters including Cmax, AUC(0-â??) and AUC(0-t) for candesartan cilexetil in relevant treatmentsTimepoint: Twenty-one (21) blood samples (1 x 5 mL) will be collected in pre-labelled K2EDTA vacutainers, during each treatment period. Single venous blood sample will be withdrawn at pre-dose (0.00) and at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
- Secondary Outcome Measures
Name Time Method To estimate secondary PK parameters of two candidate tablet formulations of candesartan (GW615775; 16mg) relative to reference candesartan cilexetil tablets (Atacand; 16mg) in healthy human subjects under fasting conditions. <br/ ><br> <br/ ><br>Plasma PK parameters: tmax, %AUCex and t½ <br/ ><br> <br/ ><br>To monitor the safety and tolerability following administration of two candidate tablet formulations of candesartan (GW615775; 16mg)Timepoint: Twenty-one (21) blood samples (1 x 5 mL) will be collected in pre-labelled K2EDTA vacutainers, during each treatment period. Single venous blood sample will be withdrawn at pre-dose (0.00) and at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose