Trials / Completed
CompletedNCT06254235
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers
Bioequivalence Study of Octreotide Acetate Microsphere Injection in Human
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | The test octreotide microsphere | A single intramuscular dose of the test octreotide microsphere 30mg, |
| DRUG | The reference octreotide microsphere | A single intramuscular dose of the reference octreotide microsphere 30mg |
Timeline
- Start date
- 2021-06-16
- Primary completion
- 2021-12-01
- Completion
- 2021-12-01
- First posted
- 2024-02-12
- Last updated
- 2024-02-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06254235. Inclusion in this directory is not an endorsement.