CTRI/2024/04/066483
Completed
Phase 2
A randomized, double blind, placebo controlled, three arm, cross-over trial to assess the bioavailability of liposomal and non-liposomal CoQ-10 formulations in plasma in healthy volunteers - NI
SPECNOVA LLC0 sites18 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SPECNOVA LLC
- Enrollment
- 18
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects must be healthy human male and female (non\-pregnant)
- •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 willing to be available throughout the study duration and should follow
- •the guidelines mentioned in the protocol.
- •4\. Subjects with no evidence of underlying disease during the pre\-study
- •screening. They must be healthy as determined by medical history and
- •physical examination, ECG, Chest X\-ray (PA View) and laboratory tests
- •performed within 7 days prior to the commencement of the study.
Exclusion Criteria
- •1\. Subjects who are allergic to CoQ 10 products or any food or other drugs.
- •2\. Subjects who had taken drugs to reduce fat or statins or vitamin supplements (including vitamin E) during the last month.
- •3\. Subject with resting hypotension (BP 140 /90\) and pulse rate below 50/min and more than 100/min.
- •4\. Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric 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 Bleeding, Hepatic\-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •6\. Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study.
- •7\. Subject who has a history of alcoholism, drug abuse or Smoking.
- •8\. Subjects who are hypersensitive to Heparin
- •9\. Subjects who participated in any other clinical study in the past three months.
- •10\. Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X ray (PA View).
Outcomes
Primary Outcomes
Not specified
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