Trials / Completed
CompletedNCT03751956
A Study Evaluating the Mass Balance of [14C]HSK3486 Emulsion Injection in Healthy Adults.
A Study Evaluating the Mass Balance and Biotransformation of [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
- Sex
- Male
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to evaluate the mass balance and biotransformation pathways of HSK3486 in healthy Chinese male subjects administered with a single intravenous dose of \[14C\]HSK3486, so as to characterize the drug's general pharmacokinetics and safety in humans and provide supportive data for reasonable use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HSK3486 | The subjects will receive an intravenous injection of 0.8 μCi/0.4 mg/kg of \[14C\]HSK3486 emulsion injection (i.e., a subject with the body weight of 60 kg is administered with a radiation dose of 48 μCi). |
Timeline
- Start date
- 2019-01-06
- Primary completion
- 2019-02-28
- Completion
- 2019-03-10
- First posted
- 2018-11-23
- Last updated
- 2019-10-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03751956. Inclusion in this directory is not an endorsement.