Trials / Completed
CompletedNCT05835934
Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK21542 in Healthy Adult Male Volunteers.
A Phase I Clinical Study on Absorption, Metabolism, and Excretion of [14C]HSK21542 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK21542 in Human.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK21542 in healthy male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [14C]HSK21542 | A single intravenous dose of 2 μg/0.212 μCi/kg \[14C\]HSK21542 in boluses within 2 minute after fasting for at least 10 hours. |
Timeline
- Start date
- 2021-06-15
- Primary completion
- 2021-09-10
- Completion
- 2021-12-20
- First posted
- 2023-04-28
- Last updated
- 2023-04-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05835934. Inclusion in this directory is not an endorsement.