| CTRI Number |
CTRI/2012/10/003074 [Registered on: 26/10/2012] Trial Registered Prospectively |
| Last Modified On: |
26/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Nisoldipine 34mg ER oral tablet |
|
Scientific Title of Study
|
A RANDOMISED, OPEN LABEL, BALANCED, SINGLE CENTRE, TWO PERIOD, TWO
TREATMENT, TWO SEQUENCE, SINGLE DOSE, CROSSOVER, BIOEQUIVALENCE STUDY OF
NISOLDIPINE 34 MG EXTENDED RELEASE TABLET TO SULAR® 34 MG EXTENDED
RELEASE TABLET |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| QHYD-0004, Version 1.0, Dated 01 June 2012 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj K Bose |
| Designation |
Associate Director Medical Research |
| Affiliation |
Quintiles Phase One Clinical Trials India Private Limited |
| Address |
Quintiles Phase One Clinical Trials India Private Limited 7th and 8th
Floor Apollo Health Street Building Apollo Health City Jubilee Hills
Hyderabad
Quintiles Phase One Clinical Trials India Private Limited 7th and 8th
Floor Apollo Health Street Building Apollo Health City Jubilee Hills
Hyderabad
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
04067127519 |
| Fax |
04067127676 |
| Email |
Dr.Manoj.Bose@quintiles.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj K Bose |
| Designation |
Associate Director Medical Research |
| Affiliation |
Quintiles Phase One Clinical Trials India Private Limited |
| Address |
Quintiles Phase One Clinical Trials India Private Limited 7th and 8th
Floor Apollo Health Street Building Apollo Health City Jubilee Hills
Hyderabad
Quintiles Phase One Clinical Trials India Private Limited 7th and 8th
Floor Apollo Health Street Building Apollo Health City Jubilee Hills
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
04067127519 |
| Fax |
04067127676 |
| Email |
Dr.Manoj.Bose@quintiles.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj K Bose |
| Designation |
Associate Director Medical Research |
| Affiliation |
Quintiles Phase One Clinical Trials India Private Limited |
| Address |
Quintiles Phase One Clinical Trials India Private Limited 7th and 8th
Floor Apollo Health Street Building Apollo Health City Jubilee Hills
Hyderabad
Quintiles Phase One Clinical Trials India Private Limited 7th and 8th
Floor Apollo Health Street Building Apollo Health City Jubilee Hills
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
04067127519 |
| Fax |
04067127676 |
| Email |
Dr.Manoj.Bose@quintiles.com |
|
|
Source of Monetary or Material Support
|
| Study Drug to be supplied by InnoPharma and study Centre will be Quintiles Phase One Clinical Trial India Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
InnoPharma Inc |
| Address |
10 Knightsbridge Road Piscataway New Jersey
United States 08854 |
| 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 |
| Dr Manoj Bose |
Quintiles Phase One Clinical Trials India Private Limited |
7th and 8th Floor
Apollo Health Street Building
Apollo Health City
Jubilee Hills
Hyderabad
Hyderabad
ANDHRA PRADESH |
04067127519
04067127676
Dr.Manoj.Bose@quintiles.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NAITHIKA Independent Ethics Committee, Hyderabad, Dr. Manoj. K. Bose (PI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hypertension |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nisoldipine (Sular) 34 mg |
34mg Single dose Oral Administration |
| Intervention |
Nisoldipine 34 mg tablet |
34mg Single Dose Oral Administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Provision of signed and dated written informed consent prior to
any study specific procedures
2. Willing and able to comply with the study procedures, restrictions
and requirements
3. Adult males and females (of non-childbearing potential) aged 18 to 45 years (inclusive) at the time of signing informed consent
4. Body mass index (BMI) 19.0 to 25.0 kg/m2 (inclusive) and a body
weight of more
than 50 kg for males and 45 kg for females
5. Volunteer must be able to communicate effectively with the study
personnel.
6. Volunteer must be non-smoker and non consumer (user) of any
tobacco containing product (not consumed any form of tobacco in
the past 6 months)
7. In general good health as determined by an experienced physician
based on a comprehensive medical history and physical
examination. Minor abnormalities in laboratory testing are allowable
if not contraindicated by this protocol, and if in the estimation of the Investigator, pose no additional risk to participation nor interference
with study procedures
8. Adequate organ function as determined by laboratory
assessments within the institutional normal range including the
following parameters: hematology, serum chemistry and serology)
9. Subjects who are negative for hepatitis B surface antigen
(HBsAg), hepatitis C antibody and human immunodeficiency virus
(HIV) I and II tests at screening
10. Females must have a negative pregnancy test at screening and
on admission to the study centre, must be of non-childbearing
potential, confirmed at screening by fulfilling one of the following
criteria:
? Documentation of irreversible surgical sterilisation by
hysterectomy, bilateral oophorectomy or bilateral salpingectomy but
not tubal ligation
? Postmenopausal; Have attained menopause at least 1 year back
11. In case if childbearing, must be using a medically acceptable
form of birth control (such as foam, jellies, diaphragm, intra-uterine
device (IUD) or abstinence for the duration of the study as judged by
the Investigator
12. Male subjects should be willing to use a condom (with
spermicide) to prevent pregnancy and drug exposure of a female
partner and refrain from donating sperm or fathering a child from the
first administration of the investigational medicinal product until 3
months after administration of the investigational medicinal product |
|
| ExclusionCriteria |
| Details |
1. Participation in any investigational study or received an
investigational drug within a period of 3 months prior to admission in
period I.
2. History of drug abuse, or alcohol dependence or abuse.
3. History of any allergies (asthma, urticaria) including drug allergies
4. Known hypersensitivity or allergy to Nisoldipine or any of the
excipients or related
drugs
5. Presence of a clinically significant disorder involving the
cardiovascular, respiratory, renal, gastrointestinal, hepatic,
immunologic, haematological, endocrine, or nervous system (s) or
psychiatric disease or other condition that may interfere with the
absorption, distribution, metabolism or excretion of the
investigational medicinal product, or would place the subject at
increased risk, as determined by the investigator(s)
6. Volunteer whose:
? Systolic blood pressure less than 90 mmHg or more than 140
mmHg, diastolic blood pressure less than 60 mmHg or more than 90
mmHg after 5 minutes rest at screening or predose in Period I
? Sitting pulse rate below 55 beats per minute or above 100 beats
per minute after 5 minutes rest
? Respiratory rate below 10 or above 20 beats per minute
? Oral temperature less than 96.2°F or more than 99.8°F
7. Clinical laboratory test value outside the acceptable reference
range and when confirmed on re-examination and deemed to be
clinically significant
8. Subject who has donated blood in the 12 weeks prior to the
admission in Period I.
9. Clinically significant illness (any body system) during the 4 weeks
prior to admission in Period I (as determined by the investigators).
10. Subject who has consumed grapefruit, grapefruit juice or/and
grapefruit containing products, Seville oranges or quinine (tonic
water) within 96 hours prior to admission in Period I.
11. Use of any prescription drug(s) in the 14 days prior to admission in Period I or over-the-counter medication or herbal medications 14
days prior to admission in Period I.
12. Positive result in breath analysis test for alcohol.
13. Positive urine drug screening results for any of the following:
cocaine, tetrahydrocannabinol, barbiturates, amphetamines,
benzodiazepines, and opioids.
14. Positive results in cotinine test.
15. History of difficulty in swallowing tablets/ capsules.
16. Positive test for pregnancy for female subjects or lactating
females
17. Inability to be venipunctured and/or tolerate venous puncture |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the oral bioequivalence of Nisoldipine
34 mg extended release tablet manufactured by
InnoPharma Inc. and Sular® (Nisoldipine) 34mg extended release tablet manufactured for
Shionogi Pharma, Inc., manufactured by
SkyePharma production SAS in healthy human
adult subjects, under fasting conditions |
Outcome will be assessed by March 2013 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor the safety of a single dose of
Nisoldipine 34mg extended release tablet when
administered in healthy human adult subjects
under fasting conditions |
Outcome will be assessed by March 2013 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/12/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No Publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To assess the oral bioequivalence of Nisoldipine 34 mg extended release tablet manufactured by InnoPharma Inc. and Sular ® (Nisoldipine) 34 mg extended release tablet manufactured for Shionogi Pharma, Inc., manufactured by SkyePharma production SAS in healthy human adult subjects, under fasting conditions
Bioequivalence of the test formulation with that of the reference formulation under fasting condition will be concluded if the 90% confidence intervals for the geometric mean ratios for C max, AUC(0-inf) and AUC(0-last) for Nisoldipine fall entirely within the acceptance range of 80.00 to 125.00%. |