The second hospital of anhui medical university
Hefei, Anhui, China
NCT Number: NCT06562088
The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Phase 1
Hefei, Anhui, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally
Administered orally
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameter : Area under the curve from time 0 to 24 hour
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameter : Maximum observed concentration
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Area under the curve from time 0 to t hour
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Time to maximum plasma concentration
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Half life
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Apparent Clearance
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Apparent volume of distribution
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Area under the curve from time 0 hour to ∞
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Area under the curve from time 0 to 24 hour
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Maximum observed concentration
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Area under the curve from time 0 to t hour
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Time to maximum plasma concentration
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters: Half life
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Apparent Clearance
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Apparent volume of distribution
Time frame: Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13
Number of subjects reporting AEs
Contact information is provided by the study sponsor or research team.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Industry
A Phase I, Open-Label, Parallel, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of Rifampicin or Itraconazole on the Pharmacokinetics of HDM1002 in Healthy Adult Chinese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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