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
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ClinicalTrials.gov Identifier: NCT01847404 |
Recruitment Status
:
Completed
First Posted
: May 6, 2013
Last Update Posted
: July 13, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcers, Duodenal and Gastric | Drug: Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one Drug: Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two Drug: ASA 100 mg tablet Drug: Pantoprazole 20 mg gastro-resistant tablet | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 by Bayer Vital GmbH, and Protium® 20 mg Gastro-resistant Tablets by Nycomed GmbH, in Healthy, Adult, Human Subjects, Under Fasting Conditions |
Actual Study Start Date : | May 14, 2013 |
Actual Primary Completion Date : | June 28, 2013 |
Actual Study Completion Date : | June 28, 2013 |
Arm | Intervention/treatment |
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Experimental: Overall Study Arm
All the subjects in this study will take part in 3 treatment periods with one of the following treatments in each period. Subjects will receive all three treatments (one per period) in a random order after an overnight fasting of at least 10 hours fast in each period. Test 1= Fixed dose combination (FDC) formulation one of a capsule containing ASA 100 mg and pantoprazole 20 mg. Test 2= FDC formulation two of a capsule containing ASA 100 mg and pantoprazole 20 mg. Reference= ASA 100 mg tablet + pantoprazole 20 mg gastro-resistant tablet
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Drug: Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one
Formulation Test 1 of a 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
Drug: Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two
Formulation Test 2 of a 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
Drug: ASA 100 mg tablet
Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany
Other Name: Aspirin Protect
Drug: Pantoprazole 20 mg gastro-resistant tablet
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
Other Name: Protium
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- Composite of pharmacokinetic (PK) parameters [ Time Frame: During each period at pre-dose, 0.167, 0.333, 0.5, 0.667, 0.833, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 16 and 24 hrs post dose ]The bioavailability of two test products was compared with the reference products after determining the plasma PK parameters: Cmax (maximum measured plasma concentration), Tmax (time of Cmax), AUC0-t (area under the plasma concentration versus time curve from time zero to the last measurable concentration), AUC0-infinity (AUC from zero to infinity), t1/2 (time required for the plasma drug concentration to decrease by one half), Kel (terminal rate constant) and AUC_% Extrap_Obs (residual area in percentage determined by formula) for ASA and pantoprazole in relevant treatments.
- Tolerability of combined ASA and pantoprazole in subjects during the study [ Time Frame: Up to 16 days ]Tolerability of combined ASA and pantoprazole in subjects during the study assessed by adverse events, laboratory tests, vital signs and electrocardiogram (ECG).

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
- 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 kilogram per meter square (kg/m^2) and <=24.9 kg/m^2, 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 Posterior Anterior (PA) view
- Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
- Female Subject is eligible to participate if she is of non-childbearing potential (surgically sterile or post-menopausal for at least 1 year); or 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
- 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.
Exclusion criteria:
- 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 Liver Function Test (LFT)'s Serum Glutamate Oxaloacetate Transaminase/ Serum Glutamate Pyruvate Transaminase (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 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 human immuno deficiency virus (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 millilitre (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 millimetres of mercury (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 96.0 degree Fahrenheit (F) and above 98.6 degree F
- Female volunteers demonstrating a positive test for pregnancy during screening or currently breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847404
India | |
GSK Investigational Site | |
Hyderabad, India, 500 013 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01847404 History of Changes |
Other Study ID Numbers: |
116480 |
First Posted: | May 6, 2013 Key Record Dates |
Last Update Posted: | July 13, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
URL: | http:// |
Keywords provided by GlaxoSmithKline:
Fixed dose combination Acetylsalicylic acid Pantoprazole |
Additional relevant MeSH terms:
Duodenal Ulcer Peptic Ulcer Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Aspirin Pantoprazole Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors |