Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

Bioequivalence Study of Octreotide Acetate Microsphere Injection in Human

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06254235
• Other study ID #: QL-YXZ2-006
• Status: Completed
• Phase: Phase 1
• Start date: June 16, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2024
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers. Participants will receive single-dose of either test or reference octreotide microsphere formulations. Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• BMI 19-28 kg/m^2, and with weight = 50 kg for male, or = 45 kg for female
• In good physical condition (without any history of disease or clinically relevantly abnormal vital sign or examination
• Agreed to use adequate contraception and did not plan for pregnancy from screening period throughout 6 months after study completion
• Fully understood and voluntarily signed the informed consent form
• With high compliance

Exclusion Criteria:

• With allergic disease or allergic to any component of the study drugs or more than two kinds of other drug, food, or beverage
• Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
• With gastrointestinal disease
• Had drug addiction within 5 years or used narcotics within 6 months before screening or positive in drug of abuse test
• With alcohol consumption > 2 units/d within 6 months before screening
• With cigarette consumption > 5/d within 3 months before screening
• Donated or lost blood > 400 mL within 3 months before screening
• Hospitalized or received surgery within 3 months before screening
• Received study drug of other clinical trial within 3 months before screening
• Received prescription drug within 14d before dosing
• Received over-the-counter drug or herb within 48h before dosing
• Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine within 72h before dosing
• Consumed alcohol within 48h before dosing or positive for breath alcohol test
• Cannot consume standard meal
• Intolerable to venipuncture
• Cannot receive intramuscular injection in the glute
• With vitamin B12 deficiency
• Had acute minor disease (common cold, diarrhea, etc.) from screening to dosing
• For pregnancy-capable female, breastfeeding or positive for pregnancy test at screening, or had unprotected sexual contact within 2 weeks before dosing
• Other reason judged by investigators

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• The test octreotide microsphere
A single intramuscular dose of the test octreotide microsphere 30mg,
• The reference octreotide microsphere
A single intramuscular dose of the reference octreotide microsphere 30mg

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-28d	The area under the concentration-time curve from dosing to Day 28	Day 0-28
Primary	AUC28-56d	The area under the concentration-time curve from Day 28 to Day 56	Day 28-56
Primary	AUC0-t	The area under the concentration-time curve from dosing to the last quantifiable time-point	Day 0-82
Primary	AUC0-8	The area under the concentration-time curve extrapolated to infinity	Day 0-82
Primary	Cmax	The maximum drug concentration	Day 0-82