| CTRI Number |
CTRI/2013/06/003713 [Registered on: 03/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
10/07/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparative bioavailability study of two test products of fixed dose combination capsule of ASA (acetylsalicylic acid) and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) under fasting conditions |
|
Scientific Title of Study
|
An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over, single dose, comparative bioavailability pilot study of two test formulations of fixed dose combination capsules of acetylsalicylic acid (ASA) and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK comparing with Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany and Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany in healthy, adult, human subjects, under fasting conditions |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BE-408-ASPA-2012 Version-02 dated 22/04/13 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anitha Singareddy |
| 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 |
| Phone |
04027032945 |
| Fax |
04027033454 |
| Email |
singareddy.anitha@piramal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anitha Singareddy |
| 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 |
| Phone |
04027032945 |
| Fax |
04027033454 |
| Email |
singareddy.anitha@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 |
| Phone |
04027032945 |
| Fax |
04027033454 |
| Email |
maddela.rambabu@piramal.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dushen J Chetty PhD |
| Address |
Emerging Markets R&D
GlaxoSmithKline
1 Pesek Road
Jurong Island
Singapore, 627833 |
| 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
Mirra Kamshetty Mall (3rd and 4th Floor)
Ramanthapur
Rangareddy District
Rangareddi
ANDHRA PRADESH |
04027032945
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 45 years of age inclusive |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg)Manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany |
Each tablet contains ASA 100 mg.
Single Oral-dose will be administered as per randomization schedule at morning session (0800-0900 am) of the drug administration day. |
| Comparator Agent |
Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate))Marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany |
Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)Single Oral-dose will be administered as per randomization schedule at morning session (0800-0900 am) of the drug administration |
| Intervention |
Test (T1): Fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg)
Manufactured by Piramal Healthcare Limited, India for GSK |
Each capsule contains ASA 100 mg and pantoprazole 20 mgSingle Oral-dose will be administered as per randomization schedule at morning session (0800-0900 am) of the drug administration |
| Intervention |
Test (T2): Fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg)
Manufactured by Piramal Healthcare Limited, India for GSK |
Each capsule contains ASA 100 mg and pantoprazole 20 mgSingle 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 |
45.00 Year(s) |
| Gender |
Both |
| Details |
–Healthy human subjects within the age range of 18 to 45 years (both inclusive)
–Non-smokers since at least six months
–Willingness to provide written informed consent to participate in the study
–Body-mass index (BMI) of  18.5 kg/m2 and  24.9 kg/m2, with body weight not less than 50 kg
–Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening
–Normal 12-lead ECG or one with abnormality considered to be clinically insignificant
–Normal chest X-ray PA view
–Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
–Female Subjects
•of child bearing potential practicing an acceptable method of birth control while in the study and for 14 days after the end of the study, as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or
•post-menopausal for at least 1 year, or
•surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject
–Male Subjects
•Willing to use an approved form of birth control (a double barrier method like condom with spermicide or condom with diaphragm) while in the study and for 14 days after the end of the study, and agree not to donate sperm during this period |
|
| ExclusionCriteria |
| Details |
–Personal / family history/ past history of allergy or hypersensitivity to ASA or pantoprazole or related drugs.
–Any contraindication to anticoagulant therapy
–History of sensitivity to heparin or heparin-induced thrombocytopenia
–Past history of active gastric or duodenal ulcer or esophagitis
–A history of cholecystectomy or biliary tract disease including increased liver function tests of known or unknown etiology
–Subjects who have been diagnosed with Gilbert’s syndrome (Elevated LFT’s (SGOT/SGPT) + Bilirubin (total and direct))
–Past history of anaphylaxis or angioedema
–Any history of myopathy
–Female subject not willing to use acceptable method of contraception from the date of screening until 14 days after the end of the study
–Male subject not willing to use acceptable method of contraception from the date of screening until 14 days after the end of the study
–Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g.congestive heart failure, hepatitis, pancreatitis etc.
–Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT) etc.
–Any cardiac, renal or liver impairment, any other organ or system impairment
–History of seizure or psychiatric disorders
–Presence of disease markers of HIV 1 and 2, and hepatitis B and C virus
–History of significant alcohol consumption for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to check-in in each period and during the study [one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit].
–Presence of painful erythema, oedema, or ulceration in the oral cavity
–Consumption of xanthine containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hours before check-in of each period
–Use of any recreational drug or a history of drug addiction
–Participation in any clinical trial within the past 3 months
–Inaccessibility of veins in left and right arm
–Donation of blood (one unit or 330 mL) within 3 months prior to study check-in
–History of use of any prescription drug therapy within four weeks or over-the-counter (OTC) drugs within two weeks prior to study check-in or repeated use of drugs within the last four weeks
–History of unusual diet, for whatever reason , e.g. low sodium diet, for 7 days prior to check-in for all the three periods
–History of consumption of grapefruit-containing food or drinks within 7 days prior to the study check-in for all the three periods
–Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 7 days prior to the study check-in for all the three periods
–Difficulty in swallowing solids like tablets/capsules
–Systolic blood pressure below 100 mm Hg and above 138 mm Hg, diastolic blood pressure below 60 mm Hg and above 90 mmHg
–Heart rate below 60 beats/minute and above 100 beats/minute
–Temperature below 96.00 F and above 98.60 F
–Female volunteers demonstrating a positive test for pregnancy during screening or currently breast-feeding
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plasma PK parameters including Cmax, Tmax, AUC0-t, AUC0-∞, t1/2, Kel and AUC_% Extrap_Obs for ASA and pantoprazole in relevant treatments |
Blood samples (1 x 6 mL) will be collected in pre labelled sodium heparin vacutainers, during each period at Pre-dose (0.00), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00 and 10.00 hrs post dose.
Also blood samples (1 x 3 mL) will be collected in pre labelled sodium heparin vacutainers, during each period at 0.167, 0.333, 0.667, 0.833, 1.25, 1.75, 3.50, 4.50, 12.00, 14.00, 16.00 and 24.00 hrs post dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the tolerability of combined administration of ASA 100 mg and pantoprazole 20 mg in the subjects participating in this study |
Blood samples (1 x 6 mL) will be collected in pre labelled sodium heparin vacutainers, during each period at Pre-dose (0.00), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00 and 10.00 hrs post dose. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2013 |
| 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="16" |
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
is an open label, balanced, randomized, three-treatment, three-period,
six-sequence, cross-over, single dose, comparative bioavailability pilot study
of fixed dose combination capsule of ASA and pantoprazole (Each capsule
contains ASA 100 mg and pantoprazole 20 mg) of test product (T1) or
(T2) or reference product (R), Aspirin® Protect 100 mg
tablets (Each tablet contains ASA 100 mg) and Protium® 20 mg
gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of
pantoprazole (as sodium sesquihydrate)) under fasting conditions |