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Ulcers, Duodenal and GastricPhase 1NCT01847417

Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fed Conditions

A Phase 1 study testing Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one, Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two and ASA 100 mg tablet in people with Ulcers, Duodenal and Gastric, run by GlaxoSmithKline at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over, single dose, comparative bioavailability pilot study under fed conditions. For fed condition, after check-in, subjects will receive a standard dinner consisting (1000 - 1200 calories) after which they will be required to fast… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Ulcers, Duodenal and Gastric
What is being tested?
Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one, Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two and ASA 100 mg tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteIndia
Study dates
16 May 2013to 1 Jul 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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.
  • Willing to consume non-vegetarian, high fat breakfast prior to dosing.
  • 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.

Who cannot join

  • 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))
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  • 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

Trial locations and contacts

1 site in 1 country.

India1 site

  • GSK Investigational Site

    Hyderabad, 500 013

Other trials in India

About this study

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 Fed Conditions

An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over, single dose, comparative bioavailability pilot study under fed conditions. For fed condition, after check-in, subjects will receive a standard dinner consisting (1000 - 1200 calories) after which they will be required to fast overnight (for at least 10 hours). Thereafter they will receive a non-vegetarian high calorie, high-fat breakfast (800-1000 calories) before dosing, and a standard meal (1700 - 1900 calories) for lunch, snacks and dinner.

Being tested
Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one, Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two, ASA 100 mg tablet, Pantoprazole 20 mg gastro-resistant tablet
Keywords
Acetylsalicylic acid, Pantoprazole, Fixed dose combination
Medical subject headings
Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation oneDrug

    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

  • Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation twoDrug

    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

  • ASA 100 mg tabletDrug

    Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany

  • Pantoprazole 20 mg gastro-resistant tabletDrug

    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

Study groups in NCT01847417
Study groupRoleWhat they receive
Overall Study ArmExperimentalAll 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 in fed condition. 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
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of pharmacokinetic (PK) parameters

    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

    Measured: 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

Secondary outcomes (1)

  1. Tolerability of combined ASA and pantoprazole in subjects during the study

    Tolerability of combined ASA and pantoprazole in subjects during the study assessed by adverse events, laboratory tests, vital signs and ECG

    Measured: Up to 16 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2013 (estimated)
  2. Study start16 May 2013
  3. Primary completion1 Jul 2013
  4. Study completion1 Jul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847417
Sponsor's protocol ID
116498
Status last verified
Jul 2017
First submitted
2 May 2013
Last updated
13 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one, Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two and ASA 100 mg tablet in people with Ulcers, Duodenal and Gastric, run by GlaxoSmithKline at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01847417.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.

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