None listed
Conditions
Interventions
Intervention1: Oral magnesium oxide: mg -500
Intervention2: magnesium oxide for both groups: oral magnesium oxide will be given for two groups in different dosages
looking for Pharmacokinetic paramete
Sponsors
SRM Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male volunteers of 18 to 45 years both years inclusive and body weight more than 50 kg Subject should be able to understand informed consent and communicate effectively Non smokers Non alcohol Willing to give informed written consent and comply with the study requirements Healthy individuals as evaluated by personal history medical history and general clinical examination Vital parameters BP should be within the range of 100 to 139 mm Hg systolic and 60 to 89 mm Hg diastolic Pulse rate should be within the range of 60 to 100 per min Respiratory rate should be within the range of 14 to 18 per min Normal biochemical hematological and urinary parameters Normal Chest X ray PA view & ECG in 12 leads Negative for HIV 1 & 2 Hepatitis B Hepatitis C and Syphilis tests Negative alcohol breath analysis to be performed on the day of check in
Exclusion criteria
Exclusion criteria: History of any major surgical procedure in the past 3 months History of diabetes mellitus tuberculosis and systemic hypertension History suggestive of cardiac gastrointestinal respiratory hepatic renal endocrine neurological metabolic psychiatric or hematological systems judged to be clinically significant History of dysphagia History of any medical disorder that is of significance in the investigators opinion Present or past history of drug abuse History of hypersensitivity to study formulation History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions Present or past history of intake of drugs which potentially modify kinetics dynamics of study medication or any other medication judged to be clinically significant by the investigator Consumption of grapefruit its products within 48 hours prior to the start of the study Intake of any prescription drug within 14 days or overthecounter OTC drugs within 7 days prior to study and or intake of any drug in the past Subject with clinically significant abnormal values of laboratory parameters Subject who had participated in any other clinical study during the last 3 months Subject who had bled in the past 3 months from the date of start of study either for blood donation or for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pharmacological parameters of oral magnesium oxideTimepoint: 15 minutes 30 minutes 45 minutes 1st 2nd 4th 6th 8th and 12th hour after the administration of the drug | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the ADRs during the study periodTimepoint: 15 minutes 30 minutes 45 minutes 1st 2nd 4th 6th 8th & 12th hour after the administration of the drug | — |
Countries
India
Contacts
Public ContactRKSWETHA
SRM Medical college and hospital,Srm nagar Potheri,603203
Outcome results
None listed