Relative bioavailability study of an 16 mg test formulation tablet of candesartan cilexetil (GW615775) under fasting conditions

Completed

Conditions: Healthy human subjects between 18 and 65 years of age inclusive

Registration Number: CTRI/2014/01/004348

Lead Sponsor: GlaxoSmithKline Research and Development Limited

Brief Summary: This study aims to determine the relative bioavailability of an 16 mg test formulation tablet of candesartan cilexetil (GW615775) compared to an 16 mg reference tablet of candesartan cilexetil (Atacand; Astra Zeneca, Argentina) in healthy adult subjects. This will be an open-label, randomised, single dose, two-way crossover study.

Each subject will participate in both treatment periods and will receive single oral doses of GW615775 and reference candesartan cilexetil (Atacand); the treatment periods will be separated by a washout period of at least 7 days and no greater than 14 days. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing.

Safety will be assessed by measurement of vital signs (blood pressure, body temperature, respiration rate and pulse rate), clinical laboratory assessments, electrocardiogram measurements and review of adverse events. The study will enrol 16 healthy subjects to ensure that 14 complete the study as planned

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 16

Inclusion Criteria

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 â‰¥ 50kg and BMI within the range 19 â€“ 24.9kg/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 â‰¤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Based on single or averaged QTc of triplicate ECGs obtained over a brief recording period: QTcF < 450 msec.

Exclusion Criteria

Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug Any subject with a systolic BP<95mmHg or with a recent history of postural symptoms.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma PK parameters: Cmax, AUC(0-âˆž) and AUC(0-t) for candesartan in relevant treatments	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
To assess the relative bioavailability of a candidate tablet test formulation of candesartan cilexetil (GW615775;16mg) relative to reference candesartan cilexetil (Atacand;16mg) in healthy human subjects under fasting conditions	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 characterise secondary PK parameters of a candidate	tablet test formulation of candesartan cilexetil

Trial Locations

Locations (1): Piramal Clinical Research
🇮🇳
Rangareddi, ANDHRA PRADESH, India
Piramal Clinical Research
🇮🇳Rangareddi, ANDHRA PRADESH, India
Maddela Rambabu
Principal investigator
04027032630
maddela.rambabu@piramal.com