| CTRI Number |
CTRI/2014/01/004348 [Registered on: 27/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
08/01/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Relative bioavailability study of an 16 mg test formulation tablet of candesartan cilexetil (GW615775) under fasting conditions |
|
Scientific Title of Study
|
An open-label, randomised, single dose, two-way crossover pilot study to determine the relative bioavailability of one 16 mg tablet formulation of candesartan cilexetil (GW615775) relative to one 16 mg reference tablet of candesartan cilexetil (Atacand) in healthy adult human subjects under fasting conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 035-BE-2013 dated 15th October 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Anil Babu |
| Designation |
Principal Investigator |
| Affiliation |
Piramal Clinical Research |
| Address |
Piramal Clinical Research Clinical Department Mirra Kamshetty Mall (3rd and 4th Floor) Ramanthapur Rangareddy District Rangareddi ANDHRA PRADESH 500013 India
Rangareddi
ANDHRA PRADESH
500013
India
Rangareddi
ANDHRA PRADESH
500013
India |
| Phone |
04027032630 |
| Fax |
04027033454 |
| Email |
nettyam.anilbabu@piramal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Anil Babu |
| Designation |
Principal Investigator |
| Affiliation |
Piramal Clinical Research |
| Address |
Piramal Clinical Research Clinical Department Mirra Kamshetty Mall (3rd and 4th Floor) Ramanthapur Rangareddy District Rangareddi ANDHRA PRADESH 500013 India
Rangareddi
ANDHRA PRADESH
500013
India
ANDHRA PRADESH
500013
India |
| Phone |
04027032630 |
| Fax |
04027033454 |
| Email |
nettyam.anilbabu@piramal.com |
|
Details of Contact Person
Public Query
|
| Name |
Maddela Rambabu |
| Designation |
Chief Manager-Operations |
| Affiliation |
Piramal Clinical Research |
| Address |
Piramal Clinical Research Clinical Department Mirra Kamshetty Mall (3rd and 4th Floor) Ramanthapur Rangareddy District Rangareddi ANDHRA PRADESH 500013 India
Rangareddi
ANDHRA PRADESH
500013
India
Rangareddi
ANDHRA PRADESH
500013
India |
| Phone |
04027032630 |
| Fax |
04027033454 |
| Email |
maddela.rambabu@piramal.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GlaxoSmithKline Research and Development Limited |
| Address |
Dr Mair Jenkins
GlaxoSmithKline Research and Development Limited 980 Great West Road Brentford Middlesex, TW8 9Gs UK |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Maddela Rambabu |
Piramal Clinical Research |
Piramal Clinical Research Clinical Department Mirra Kamshetty Mall (3rd and 4th Floor) Ramanthapur Rangareddy District Rangareddi ANDHRA PRADESH 500013 India
Rangareddi
ANDHRA PRADESH
500013
India
Rangareddi
ANDHRA PRADESH |
04027032630
04027033454
maddela.rambabu@piramal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Samkshema Independent Ethics Committee, Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human subjects between 18 and 65 years of age inclusive |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atacand® 16 mg tablet (Each tablet contains candesartan Cilexetil 16 mg) Manufactured by Astra Zeneca, Sweeden SE-151 85 Södertälje, Supplied by M/s. Laboratorios Phoenix S.A.I.C.F. Juan G. Lemos 2809 – B1613 AUE, Los Polvorines – Buenos Aires, Argentina |
Each tablet contains 16 mg candesartan Cilexetil Single Oral-dose will be administered as per randomization schedule at morning session (0800-0900 am) of the drug administration |
| Intervention |
GW615775 16 mg candesartan Cilexetil tablet. Manufactured by Laboratorios Phoenix S.A.I.C.F. Juan G. Lemos 2809 – B1613 AUE Los Polvorines – Buenos Aires, Argentina |
Each tablet contains 16 mg candesartan Cilexetil Single Oral-dose will be administered as per randomization schedule at morning session (0800-0900 am) of the drug administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 ≥ 50kg and BMI within the range 19 – 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 ≤ 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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
Plasma PK parameters: Cmax, AUC(0-∞) 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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To characterise secondary PK parameters 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.
Plasma PK parameters: tmax, %AUCex and t½
Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements,review of adverse events and clinical laboratory
safety data |
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 |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |