A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects

NCT05108350 | Unknown Phase 1

• 1 other identifier: HR20033-101
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets. The primary objective is to evaluate bioequivalence of SHR3824 and Metformin in healthy Chinese subjects in the fed state. The secondary objective is to evaluate the safety of HR20033 FDC tablet in healthy Chinese subjects.

Conditions

Type II Diabetes

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax

  Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8

• Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-t

  Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8

• Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-inf (if applicable)

  Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8

Secondary Outcomes (8)

• Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Tmax

  Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8

• Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Vz/F

  Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8

• Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: CL/F

  Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8

• Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: t1/2

  Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8

• Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Tmax

  Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8

Study Arms (4)

HR20033 FDC 5/500 mg

EXPERIMENTAL

Drug: T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR

SHR3824 5mg + Metformin 500 mg XR

EXPERIMENTAL

Drug: T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR

HR20033 FDC 5/1000 mg

EXPERIMENTAL

Drug: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR

SHR3824 5 mg + Metformin 1000 mg XR

EXPERIMENTAL

Drug: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR

Interventions

T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR DRUG

SHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment T1 followed by 7 days washout and then receive treatment R1+R.

HR20033 FDC 5/500 mg

T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR DRUG

SHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment T2 followed by 7 days washout and then receive treatment R2+R.

HR20033 FDC 5/1000 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
• Must be able to communicate with the investigator, understand and comply with all study requirements;
• Subject (include their fere) must have not pregnancy plan from 2 weeks prior to dose administration to 6 months after last dose administration and must use effective form of birth control;
• Male or female subjects aged 18 to 50 (including 18 and 50);
• Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 18 and \<28 kg/m2. BMI = weight (kg)/\[height (m)\]2;
• No clinically significant deviation from normal in medical history, vital signs, physical examination.

You may not qualify if:

• Regular smoker within 3 months prior to study drug administration, or quitting smoking less than 30 days until screening;
• History of allergy to test drugs, allergic constitution (multiple drug and food allergies);
• A history of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); those who have abstained from alcohol have not quit for 30 days at the time of screening;
• Donate blood or lose a lot of blood (\>450mL) within three months before screening;
• Take any drugs that alter liver enzyme activity 28 days before screening;
• Take any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before screening;
• Those who have taken a special diet (including pitaya, mango, grapefruit, etc.) or exercised vigorously within 2 weeks before screening, or other factors that affect drug absorption, distribution, metabolism, and excretion;
• Combine the following inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone;
• Significant changes in diet or exercise habits recently;
• Have taken the research drug or participated in the drug clinical trial within three months before taking the research drug;
• Have a history of dysphagia or any gastrointestinal disease that affects drug absorption;
• Suffer from any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
• Subjects who cannot tolerate standard meals (two boiled eggs, a slice of buttered bacon toast, a box of fried potato chips, a cup of whole milk);
• Abnormal ECG has clinical significance;
• Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or the test;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Sheng Feng, Ph.D

CONTACT

13817253036; Sheng.feng@hengrui.com

Jing Rao, M.M

CONTACT

17612186457; jing.rao@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be two independent cohorts of subjects who will each receive two treatments (high dose strength and low dose strength), and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability. In each cohort approximately 40 healthy subjects will be randomized to receive treatment with IP to complete at least 36 evaluable subjects.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 4, 2021
• Study Start: November 9, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 10, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-11