Pharmacokinetic and Tolerance Study of TQ-A3326 in Healthy Participants.
NCT ID: NCT03714568
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2018-11-11
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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TQ-A3326
TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses）
TQ-A3326
TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses）
placebo
Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)
placebo
Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)
Interventions
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TQ-A3326
TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses）
placebo
Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)
Eligibility Criteria
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Inclusion Criteria
* The body weight of male is not less than 50kg, and female is not less than 45kg. All participants' body mass index (BMI) is between 19\~26.
* Adequate blood cell counts, kidney function and liver function.
* Healthy participants should participate in the study voluntarily and sign informed consent.
Exclusion Criteria
* Subject is on a special diet (for example subject is vegetarian).
* Medical demographics with evidence of clinically significant deviation from normal medical condition.
* Female subjects who were pregnant or nursing.
* Results of laboratory tests which are clinically significant.
* Acute infection within one week preceding first study drug administration.
* History of drug or alcohol abuse.
* Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
* Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
* ale subjects (or their partner) or female subjects have the unprotective sex behavior or have a planned pregnancy during the trial.
18 Years
60 Years
ALL
Yes
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Third Hospital of Changsha
Changsha, Hunan, China
Countries
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Central Contacts
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Other Identifiers
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ZDTQ-A3326-1
Identifier Type: -
Identifier Source: org_study_id