DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin

Phase 1

Completed

• Conditions: Drug Interaction
• Interventions: Drug: Dorzagliatin

• Registration Number: NCT04080596
• Lead Sponsor: Hua Medicine Limited

Brief Summary

The purpose of this study is to investigate the impact of itraconzaole on the pharmacokinetics of Dorzagliatin.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-13
• Primary Completion: 2017-12-05
• Study Completion: 2017-12-05
• Status Verified: 2019-09
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Last Update Submitted: 2019-09-04
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age 30-65
• Body weight ≥ 50 kg
• BMI ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2
• HbA1c ≥ 7% and ≤ 10.5%
• FPG ≥ 7.5 mmol/L and ≤ 13.3 mmol/L

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Exclusion Criteria

• T1DM
• Use of prescription or OTC medications, and herbal within 14 days prior to dosing
• Blood donation
• Any surgery or treatment that may impact the ADME of the drug

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sequential arm	Dorzagliatin	Dorzagliatin administered alone on Day 1; after wash-out, intraconazole was administered from Day 8 to Day 15, with Dorzagliatin administered together on Day 11.

Primary Outcome Measures

Name	Time	Method
AUClast	up to 96 hours	Area under the curve
Cmax	up to 96 hours	Peak concentration

Trial Locations

Locations (1)

The 2nd Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China