An open label, single arm, pilot study to determine the bioavailability of Liposomal CoQ-10 in three (3 no) healthy human volunteers - NI

SPECNOVA LLC0 sites0 target enrollmentStarted: TBDLast updated: April 1, 2024

Trial Snapshot

No summary available.

•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 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.
•5.Subjects whose screening laboratory values are within normal limits or considered by the physician or Principal Investigator to be of no clinical significance.

•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 in the last month.
•3.Subject with resting hypotension (BP less than 90 to 60) or hypertension (BP greater than 140 to 90) and pulse rate below 50 per min and more than 100 per 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).
•11.Subject who has difficulty with donating blood.
•12.Subject with history of difficulty in swallowing.
•13.Subject who has unsuitable veins for repeated venipuncture.

Sponsor

SPECNOVA LLC