None listed
Conditions
Interventions
Intervention1: Magnesium Oxide 240mg Capsules: After an overnight fast of at least 10.00 hours, a single
dose of three capsule of the study drug T1
(Magnesium Oxide) shall be allocated as per the
Sponsors
M/s. Aurea Biolabs (P) Limited.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study. 2) Participants with normal baseline serum magnesium levels (1.7 2.2 mg/dL (0.70 0.95 mmol/L)), within the institutional reference range. 3) Willing to be available for the entire study period and to comply with protocol requirements. 4) Normal, healthy, adult, human male subject of 25-50 years (both inclusive) of age. 5) Body mass index in the range of 18.5 29.9 kg/m2 (both inclusive), Body weight Not less than 50 kg for male at the time of screening. 6) Healthy volunteers who are clinically non anemic shall be included as per the discretion of PI/CI/Physician. 7) Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period. 8) With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis. 9) Negative urine test for drug of abuse for opioids, barbiturates, benzodiazepines, amphetamine, THC & cocaine performed on the day of check-in of each period). 10) Negative alcohol breath or urine tests for drug abuse during check-in of each study period. 11) With a normal or clinically non-significant 12-lead ECG. 12) With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies. 13) Non-smokers and willing to abstain from smoking or chewing any tobacco containing product for at least 72.00 hours prior to dosing if have history of smoking habit and throughout the sampling points. 14) Male volunteer Willing to use appropriate contraceptive measures to ensure that his female partner shall not get pregnant for at least 15 days post last-dose/ entire study period. 15) Able to read and understand the Informed Consent Document as a whole and communicate effectively if required.
Exclusion criteria
Exclusion criteria: 1) Presence or history of any clinically significant disease or disorder including but not limited to cardiovascular, hepatic, renal, gastrointestinal, endocrine, neurological, or hematological disorders. 2) Evidence of magnesium deficiency or high magnesium levels at screening. Hypomagnesemia defined as serum magnesium less than 1.7 milligram per deciliter and hypermagnesemia defined as serum magnesium greater than 2.2 milligram per deciliter. 3) History of gastrointestinal diseases or surgeries that may impair magnesium absorption including Crohn disease, celiac disease, inflammatory bowel disease, gastric bypass surgery, or major intestinal surgery. 4) Use of any prescription medication, over the counter medication, herbal product, or dietary supplement known to affect magnesium metabolism, oxidative stress, or glutathione levels within four weeks prior to dosing. 5) Any medical or surgical condition which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs. 6) History or presence of gastric or duodenal ulcer, gastrointestinal bleeding, or blood in stools at any time in the past, including history of chronic lymphocytic leukemia or small cell lymphocytic leukemia. 7) History of severe infection or major surgery within the past six months. 8) History of minor surgery or fracture within the past three months. 9) Significant history or current evidence of malignancy or chronic infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, endocrine, hematological, gastrointestinal, immunological, or psychiatric disease, or organ dysfunction. 10) Any major illness or hospitalization within ninety days prior to check in of the first study period. 11) Participants who have been on an unusual diet with low sodium intake or abnormal dietary habits, including fasting due to religious or other reasons, during four weeks prior to check in of the first study period and throughout the duration of the study until the post study safety sample is collected. 12) Use of any depot injection or implant containing any drug within three months prior to check in of the first study period and throughout the duration of the study until the post study safety sample is collected. 13) Use of any prescribed medication including herbal medicines and vitamin supplements within thirty days prior to check in of the first study period and throughout the duration of the study until the post study safety sample is collected. 14) Use of any over the counter products within fourteen days prior to first check in and throughout the duration of the study until the post study safety sample is collected. 15) Use of strong inhibitors of cytochrome P three A or preparations containing St John wort. 16) Use of any recreational drug or history of drug addiction. 17) Participation in any clinical investigation requiring repeated blood sampling, blood donation, or otherwise leading to blood loss greater than five hundred milliliter within ninety days prior to first check in. 18) Participation in any clinical study within ninety days prior to check in. 19) Consumption of alcohol or alcoholic products within seventy two hours prior to check in in each study period and throughout the sampling time points. 20) Consumption of xanthine or its derivatives containing food or bev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the systemic pharmacokinetic profiles of common magnesium salts (Magnesium Oxide Vs Magnesium Bisglycinate Vs Magnesium Citrate) in healthy adult male participants under fasting conditions.Timepoint: The venous blood samples shall be withdrawn at check in night (-11.00 hrs pre-dose) and at dosing day prior to dosing (00.00 hour) and at 00.50, 01.00, 02.00, 04.00, 06.00, 08.00, 10.00, 12.00 and 24.00 hours post-dose following drug administration in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To observe any changes in renal function tests and liver function tests from baseline findings at the time of screening and post-study.Timepoint: Liver function Test and Renal Function Test shall be done at screening and post study safety evaluation;Total serum magnesium concentrationTimepoint: At -11.00 and 00.00 hrs pre-dose and at 00.50, 01.00, 02.00, 04.00, 06.00, 08.00, 10.00, 12.00 and 24.00 hours post-dose.;Magnesium excretion in urineTimepoint: 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post dose.;To monitor or assess safety and tolerability of the magnesium capsules in healthy adult male participants under fasting conditions.Timepoint: Vital signs (blood pressure, pulse rate, respiratory rate and axillary temperature) and well-being shall be done before check-in, at pre-dose (within 02.00 hrs before dosing), and at 03.00, 07.00 and 11.00 hrs after dosing (within 60 min of scheduled time of recording), at the time of check-out in each period. The well-being of participants shall be ascertained at each vital sign measurement. | — |
Countries
India
Contacts
Public ContactLakshmikar B V
ICBio Clinical Research Private Limited
Outcome results
None listed