None listed
Conditions
Interventions
Intervention1: Qulanta Tablet: An antacid tablet
Each tablet contains
Magaldrate 400mg
Simethicone 20 mg
Dose: One tablet to be given by three diferent methods - Chew, Suck and swallow
Route: Oral
Con
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: •Healthy male volunteers with age ranging from 18 to 45 years •Non-smokers •Written informed consent by volunteers. •Volunteers willing to follow up
Exclusion criteria
Exclusion criteria: •Patient with existing GI disease (loose motion, acidity, vomiting, ulcers) •Patient who have undergone GI surgery. •Patients with known hypersensitivity to model antacid, to compounds structurally related to the study drugs or to any other component included •History of hypersensitivity to any allergens known to them •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric or any other body system involvement •History of significant symptoms of cardiac dysfunction within one year •Any history or presence of significant alcoholism or drug abuse within past one year •History or presence of significant smoking (10 or more cigarettes per day) or consumption of tobacco products •History or presence of significant asthma, urticaria or other allergic reactions following antacid •History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor •Blood pressure less than 90/60 (Systolic/ diastolic) mm Hg or more than 140/95 mm hg •Pulse less than 45/minute or more than 110/minute •Febrile patients •Use of any prescription medication during last two weeks or OTC medicinal products during the last one-week preceding the study •Major illness during 3 months before the screening period. •Subjects who have been on abnormal diet for whatever reason during 4 weeks preceding the study •Subjects who have participated in drug research study within past three months •A positive Pregnancy test in case of female volunteer of child bearing age •Subject planning to leave the area of study before completion of study •Planed participation in another clinical trial during the trial period •Any other condition that in the opinion of the investigator does not justify the patientâ??s participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dispersion pattern of study medication in each groupTimepoint: Gamma Imaging shall be done after the administration of the study medications at following time points Dynamic images will be taken at every 30 sec upto 30 mins after dose Static images will be taken at 1 hour & 2 hours after dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of food on dispersion pattern of antacid tablet and antacid suspensionTimepoint: After 2 days at the end of study | — |
Countries
India
Contacts
Public ContactDr Sanjay Maroo
Troikaa Pharmaceuticals Limited
Outcome results
None listed