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

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

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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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