Pharmacokinetic and Tolerance Study of TQ-A3326 in Healthy Participants.

C

CTTQ

Status and phase

Unknown
Phase 1

Conditions

Pharmacokinetic

Treatments

Drug: TQ-A3326
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03714568
ZDTQ-A3326-1

Details and patient eligibility

About

To study the single dose and multi-doses pharmacokinetic characteristics and tolerance of TQ-A3326 in the human body;To study the transformation of TQ-A3326;To study the effect of the food on the pharmacokinetic characteristics of TQ-A3326.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male or female, age 18 to 60 years, inclusive.
  • 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

  • Subjects with known allergy to the similar products tested.
  • 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.

Trial design

60 participants in 2 patient groups

TQ-A3326
Experimental group
Description:
TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses)
Treatment:
Drug: TQ-A3326
placebo
Experimental group
Description:
Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)
Treatment:
Drug: placebo

Trial contacts and locations

0

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Central trial contact

Li Xin, Doctor

Data sourced from clinicaltrials.gov

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