| CTRI Number |
CTRI/2014/04/004526 [Registered on: 07/04/2014] Trial Registered Prospectively |
| Last Modified On: |
06/05/2014 |
| 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 fixed dose combination tablet formulation of GSK587323 (16mg candesartan cilexetil/12.5mg hydrochlorothiazide) under fasting conditions |
|
Scientific Title of Study
|
An open-label, randomised, single dose, two-way crossover pilot study to determine the relative bioavailability of a fixed dose combination tablet formulation of GSK587323 (16mg candesartan cilexetil/12.5mg hydrochlorothiazide) relative to respective reference dosage Atacand D in healthy adult human subjects under fasting conditions |
| Trial Acronym |
Asian |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 042-BE-2013 dated 05-DEC-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 |
Mirra Kamshetty Mall (3rd and 4th Floor)
Ramanthapur
R.R.District
Hyderabad
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 |
Mirra Kamshetty Mall (3rd and 4th Floor)
Ramanthapur
R.R.District
Hyderabad
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 |
Mirra Kamshetty Mall (3rd and 4th Floor)
Ramanthapur
R.R.District
Hyderabad
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 M.B.B.S.- Director
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 Rambau |
Piramal Clinical Research |
Mirra Kamshetty Mall (3rd and 4th Floor)
Ramanthapur
R.R.District
Hyderabad
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 |
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 |
| Intervention |
16mg candesartan cilexetil/12.5mg HCTZ (GSK587323) FDC tablet Manufactured by Laboratorios Phoenix S.A.I.C.F. Juan G. Lemos 2809 – B1613 AUE Los Polvorines – Buenos Aires, Argentina |
Each tablet contains 16mg candesartan cilexetil/12.5mg HCTZ Single Oral-dose will be administered as per randomization schedule at morning session (0800-0900 am) of the drug administration |
| Comparator Agent |
Atacand D (containing 16mg candesartan cilexetil/12.5mg HCTZ) tablet Manufactured by Astra Zeneca, Sweden 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 16mg candesartan cilexetil/12.5mg HCTZ 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 formulation of candesartan and HCTZ following administration of a FDC of 16mg candesartan cilexetil/12.5mg HCTZ (GSK587323) relative to reference FDC of 16mg candesartan cilexetil/12.5mg HCTZ (Atacand D) in healthy human subjects under fasting conditions.
Plasma PK parameters including Cmax, AUC(0-∞) and AUC(0-t) for candesartan cilexetil and HCTZ in
relevant treatments |
Twenty-four (24) blood samples (1 x 6 mL)pre-dose (0.00) and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 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 FDC tablet formulation of 16mg candesartan cilexetil/12.5mg HCTZ (GSK587323) relative to reference 16mg candesartan cilexetil/12.5mg HCTZ (Atacand D) in healthy human subjects under fasting conditions.
Plasma PK parameters: tmax, %AUCex and t½ |
Twenty-four (24) blood samples (1 x 6 mL)pre-dose (0.00) and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 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)
|
09/04/2014 |
| 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="24" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
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 a fixed dose combination (FDC) tablet formulation of GSK587323 (16mg candesartan cilexetil/12.5mg hydrochlorothiazide) relative to the reference product Atacand D (16mg candesartan cilexetil/12.5mg hydrochlorothiazide, 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 a single oral dose of the FDC of GSK587323 and reference Atacand D. Treatment periods will be separated by a washout period 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. |