None listed
Conditions
Interventions
Intervention1: Nitrocontin Controlled Release tablet 2.6 mg (Nitroglycerin): Name of the drug:Nitroglycerin 2.6 mg controlled release tablet
Route of administration: Oral Frequency: single oral dose S
Sponsors
Modi-Mundi Pharma Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1 Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2 Willing to be available for the entire study period and to comply with protocol requirements 3 Normal healthy adult human subject of 18 45 years both inclusive of age 4 Body mass index in the range of 18 30 kg m2 both inclusive and weight at least 50kg 5 Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician
Exclusion criteria
Exclusion criteria: 1 Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs 2 History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past 3 History of severe infection or major surgery in the past 6 months 4 History of Minor surgery or fracture within the past 3 months 5 Significant history or current evidence of malignancy or chronic infectious cardiovascular renal hepatic ophthalmic pulmonary neurological metabolic endocrine hematological gastrointestinal immunological or psychiatric diseases or organ dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-8Timepoint: From Day 01 to Day 09 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, ?z and t1/2Timepoint: From Day 01 to Day 09 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed