None listed
Conditions
Interventions
Intervention1: Gastroretentive slow release DTPA tablet: Dose: 200mg
Duration of study protocol: 2 days (24 hr study)
Control Intervention1: NIL: NIL
Sponsors
Defence R&D Organisation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (18-70 years of age) 2. On no medication 3. Normal swallowing reflux 4. Ability to swallow whole tablets 5. Ability to remain empty stomach for at least 8 hours
Exclusion criteria
Exclusion criteria: 1. Patients with gastric conditions: medical or surgical 2. Patients with gall bladder disease or surgery 3. Those unable to lie down in stable condition for scintigraphy 4. Pregnant & lactating women or women of child bearing potential not using medically accepted methods of contraception. 5. Patients with clinically significant renal, respiratory, cardiac, gastrointestinal, hepatic, endocrine or hematological disorders. 6. Patients with abnormalities in gastric function or emptying 7. Patients who have any medical condition which in the judgement of the investigator may render them in appropriate for participation in the trial. 8. Patients who have received any other investigational drug for the last 3 months
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To establish safety & patient acceptability of the developed slow-release gastroretentive DTPA formulationTimepoint: NIL | — |
Primary
| Measure | Time frame |
|---|---|
| To confirm and quantify gastric retention and release pattern of DPTA from the slow-release gastroretentive DTPA oral formulation through pharmacoscintigraphyTimepoint: NIL | — |
Countries
India
Contacts
Public ContactAseem Bhatnagar
Institute of Nuclear Medicine & Allied Sciences, Defence R&D Organisation, Ministry of Defence
Outcome results
None listed