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CTRI Number  CTRI/2012/11/003091 [Registered on: 08/11/2012] Trial Registered Retrospectively
Last Modified On: 03/11/2012
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 8.5mg 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 8.5 MG EXTENDED RELEASE TABLET TO SULAR® 8.5 MG EXTENDED RELEASE TABLET 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  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
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
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. Study site at Quintiels Phase One clinical trial India Pvt. Ltd., Hyderabad 
 
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  
Name  Address 
NIL  NIL 
 
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 and Dr. Manoj K Bose (PI)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hypertension 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nisoldipine 8.5 mg ER tablet  8.5mg Single dose for Oral administration 
Comparator Agent  Nisoldipine(Sular) 8.5mg ER tablet  8.5mg 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 investigato(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 8.5 mg extended release tablet manufactured by InnoPharma Inc. and Sular® (Nisoldipine) 8.5 mg extended release tablet manufactured for Shionogi Pharma, Inc., manufactured by SkyePharma production SAS in healthy human adult subjects, under fasting conditions  Single dose of Nisoldipine 8.5mg for 2 period 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety of a single dose of Nisoldipine 8.5mg extended release tablet when administered in healthy human adult subjects under fasting conditions  Single dose of Nisoldipine 8.5mg for 2 period 
 
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)   15/10/2012 
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)  Open to Recruitment 
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 8.5 mg extended release tablet manufactured by InnoPharma Inc. and Sular® (Nisoldipine) 8.5 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 Cmax, AUC(0-inf) and AUC(0-last) for Nisoldipine fall entirely within the acceptance range of 80.00 to 125.00%.

 
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