CTRI/2023/04/051789
Completed
未知
A randomized, double blind, placebo controlled, three arm, cross-over trial to assess thebioavailability of liposomal and non-liposomal Vitamin-C formulations in plasma and leukocytes inhealthy volunteers
SPECNOVA0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SPECNOVA
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects must be healthy human male and female (non\-pregnant) subjects.
- •2\.Age should be between 18\-45 years of age (both inclusive), weighing at least 50 kg.
- •3\.Subject who are ready to provide written informed consent and should be
- •4\.willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol.
- •5\.Subjects with no evidence of underlying disease during the pre\-study screening.
- •6\.They must be healthy as determined by medical history and physical examination, ECG, Chest X\-ray (PA View) and laboratory tests
- •7\.performed within 7 days prior to the commencement of the study.
- •8\.Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
Exclusion Criteria
- •1\.Subjects who are allergic to vitamin C products or any food or other drugs.
- •2\.Subject with resting hypotension (BP \<90 /60\) or hypertension (BP \> 140 /90\) and pulse rate below 50/min and more than 100/min.
- •3\.Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric
- •4\.disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in\-housing.
- •5\.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI
- •6\.Bleeding, Hepatic\-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •7\.Subjects who have taken over the counter or prescribed medications
- •8\.including any enzyme modifying drugs within the last 14 days prior to the study.
- •9\.Subject who has a history of alcoholism, drug abuse or Smoking.
- •10\.Subjects who are hypersensitive to Heparin Subjects who participated in any other clinical study in the past three months.
Outcomes
Primary Outcomes
Not specified
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