Healthy Volunteer Clinical Trial
Official title:
Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules
Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a
significant cholesterol lowering effect which might be caused by addictive and/or
synergistic effects of lovastatin (monacolin K) with other monacolins and substances in
capsules. The usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is
one capsule twice/day.
However, the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte)is still
unknown.
The objective of the study is to evaluate the pharmacokinetic profile of red yeast rice
capsule (LipoCol Forte) after administering single and multiple dose to healthy subjects.
This study will divide into two groups, single and multiple doses groups. In single dose
group, the subjects will receive one, two and four red yeast rice capsules under fed state
in period one to three, respectively. In multiple doses group, the subjects will receive red
yeast rice capsules under fed state twice daily for 4.5 days. There is a minimum of a 5-days
washout period before crossover of treatments.
In single dose treatment, the blood samples will be drawn prior to the dosing, and 0.5, 1,
1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the dosing.
In multiple doses treatment, the blood samples will be drawn prior to the 1st dosing, prior
to the 7th dosing, prior to the 8th dosing, prior to the 9th dosing, and 0.5, 1, 1.5, 2,
2.5, 3, 4, 6, 8 and 12 hours after the 9th dosing.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06326723 -
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT00001367 -
Diagnosis and History Study of Patients With Different Neurological Conditions
|
||
| Completed |
NCT02699710 -
Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02231892 -
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
|
N/A | |
| Not yet recruiting |
NCT06441916 -
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
|
Phase 1 | |
| Completed |
NCT03771586 -
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT06337422 -
Bioequivalence Study of Generic Celecoxib 200 mg Capsules
|
Phase 1 | |
| Completed |
NCT03302182 -
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT05049343 -
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
|
Phase 1 | |
| Recruiting |
NCT01629108 -
Normal Values in Hearing and Balance Testing
|
||
| Completed |
NCT02947854 -
Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant
|
Phase 1 | |
| Completed |
NCT02534870 -
Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT02224053 -
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01711762 -
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01697436 -
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
|
Phase 1 | |
| Completed |
NCT01684891 -
A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01676584 -
A Study of Single Dose RO6811135 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01433575 -
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers
|
Phase 1 | |
| Completed |
NCT02547259 -
Influence of Emotion in a Test Run Forgetfulness
|
N/A | |
| Completed |
NCT01414881 -
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
|
Phase 1 |