NCT04972045

Bioavailability of Curcumin Capsules in Healthy Adult Subjects

Bioavailability of Curcumin Capsules in Healthy Adult Subjects: an Open, Randomized, Single-dose, Two-period, Two-sequence Crossover Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: —
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A single-center, open-label, randomized, two-period, crossover study design of pharmacokinetics and bioavailability in healthy adult male and female subjects under fasting conditions.

Detailed description

Upgraded curcumin capsules(CuminUP60®) is made from curcumin with a natural extraction content of 95% and excipients through physical process microprocessing, with a curcumin content of more than 60%. CuminUP60® capsules are 400 mg/ capsules and ordinary curcumin capsules are 400 mg/ capsules. The main purpose of this study is to evaluate the bioavailability by comparing the pharmacokinetics of CuminUP60® capsule with that of curcumin capsule before the prescription improvement. 12 cases are planned to be enrolled.According to the random table, each subject will be randomly assigned to one of two groups (group 1: A/B, group 2: B/A). The cleaning period between the two doses is 7 days. Subjects were given the test preparation (A) or the control preparation (B) on the first day of the first cycle of the trial, and were temporarily allowed to leave the phase I clinical research center after 72 hours of blood sample collection and vital signs examination after the completion of the medication. After a 7-day wash period, on the 8th day of the second cycle, the subject will be cross-administered with the control formulation (B) or the test formulation (A), all procedures are the same as in the first cycle. On the 11th day (the second cycle), subjects will undergo physical examination, ECG examination, assessment of vital signs (blood pressure, pulse, body temperature), laboratory examinations (blood biochemistry, blood routine, urine routine, detailed examination items are shown in the appendix 1) Female subjects must undergo a blood pregnancy test and then be allowed to leave the research center.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	CuminUP60®	4 capsules, 400 mg / capsule
DRUG	Curcumin capsules	4 capsules, 400 mg / capsule

Timeline

• Start date: 2021-04-09
• Primary completion: 2021-04-23
• Completion: 2021-06-22
• First posted: 2021-07-22
• Last updated: 2021-08-10

Locations

1 site across 1 country: China