Phase I clinical study on the safety, tolerance and pharmacokinetics of BGT-002 tablets of single center, randomized, open, two cycles, two sequences and two crossover design after single administration in healthy subjects under fasting and high-fat postprandial conditions

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Group A:In the first cycle, the drug was administered on an empty stomach, and in the second cycle, the drug was administered after a high‐fat meal;Group B:In the first cycle, the drug was administered after a high‐fat meal, and in the second cycle, the drug was administered on an empty stomach; CONDITION: hypercholesterolemia PRIMARY OUTCOME: Pharmacokinetic (PK) characteristics of single oral administration of BGT‐002 tablets; SECONDARY OUTCOME: Vital sign examination;physical examination;ECG;laboratory examination; INCLUSION CRITERIA: 1) Aged between 18 to 45, male or female; 2) Weight: male>50 kg, female>45 kg; 19 kg/m2
Epistemonikos ID: 7107fb7e5deef9479543747df5dad9aa1a72e41d
First added on: Feb 20, 2024