DDI Study Between Dorzagliatin and Rifampicin
Sponsor
Hua Medicine Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04080609
Collaborator
(none)
15
1
1
21
21.7
Study Details
Study Description
Brief Summary
The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
15 participants
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, Open Label, Drug-drug Interaction Study to Investigate the Pharmacokinetics and Safety of Dorzagliation Administered Alone or in Combination With Rifampicin in Healthy Subjects
Actual Study Start Date
:
Mar 27, 2018
Actual Primary Completion Date
:
Apr 17, 2018
Actual Study Completion Date
:
Apr 17, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequential arm Dorzagliatin was administered single dose; after wash-out, rifampicin was dosed continuously for 9 days, with Dorzagliatin dosed simultaneously on day 8. |
Drug: Dorzagliatin
GKA currently under clinical development
|
Outcome Measures
Primary Outcome Measures
- Cmax [up to 96 hours]
Peak plasma concentration
- AUClast [up to 96 hours]
Area under the plasma concentration curve
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Body weight ≥ 50 kg (male) or ≥ 45 kg (female)
-
BMI within 19～26 kg/m2
Exclusion Criteria:
-
History or disease status that may impact the ADME of the study
-
Use of any drugs, OTCs, or hebal within 4 weeks of screening
-
Drug abuse
-
Blood donation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Hospital of Xuhui District | Shanghai | Shanghai | China | 201203 |
Sponsors and Collaborators
- Hua Medicine Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hua Medicine Limited
ClinicalTrials.gov Identifier:
NCT04080609
Other Study ID Numbers:
- HMM0108
First Posted:
Sep 6, 2019
Last Update Posted:
Sep 6, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No