Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

NCT ID: NCT06579053

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2023-08-23

Brief Summary

The goal of this clinical trial is to Evaluate the Bioequivalence of Spironolactone Tablets 100mg (by SPH Sine Pharmaceutical Laboratories Co.,Ltd) and ALDACTONE® tablets 100mg (by GD SEARLE LLC) in Chinese Healthy Adult Volunteers under Fasting and Fed Conditions. It will also learn about the safety of the two drugs.

Conditions

Bioequivalence Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test product

Spironolactone Tablets, 100 mg/tablet, to be orally administered.

Group Type: EXPERIMENTAL

Spironolactone Tablets (Test)

Intervention Type: DRUG

Take one test tablet each period

Reference product

ALDACTONE® Tablets,100 mg/tablet, to be orally administered.

Group Type: ACTIVE_COMPARATOR

Spironolactone Tablets (Reference)

Intervention Type: DRUG

Take one reference tablet each period

Interventions

Spironolactone Tablets (Test)

Take one test tablet each period

Intervention Type: DRUG

Spironolactone Tablets (Reference)

Take one reference tablet each period

Intervention Type: DRUG

Other Intervention Names

ALDACTONE® tablets

Eligibility Criteria

Inclusion Criteria

1. 18 years old ≤ age ≤ 40 years old, male or female;

2. Weight: ≥ 50 kg for male and ≥ 45 kg for female; body mass index (BMI) in the range of 19-26 kg/m2 (including 19 and 26);

3. No history of heart, liver, kidney, gastrointestinal, nervous system, mental abnormalities and metabolic abnormalities, no history of allergy to agents, no history of serious infections and serious injuries, etc;

4. Physical examination, vital signs examination, electrocardiogram examination, and laboratory examination of important indicators are normal or within the range considered acceptable by the sponsor/investigator;

5. No parenting plan and access to reliable contraception during the trial and within 3 months of the last dose;

6. Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the ICF, and be able to complete the entire trial process according to the trial requirements.

Exclusion Criteria

1. Persons with a known history of allergy, allergic disorder or hypersensitivity to the test product and any of its components or related agents;

2. Persons with a clear history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic disorders (e.g. hyperkalemia) or other diseases that are not suitable for participation in clinical trials (e.g. history of psychiatric disorders, etc.);

3. Those who have donated blood or lost ≥ 400 mL of blood within 3 months prior to enrollment;

4. Those who have taken any medication within 2 weeks prior to screening;

5. Those who have participated in other drug clinical trials within 3 months prior to enrollment;

6. current or former drug abuser or alcohol addict who consumes alcohol at least 2 times a day or 14 or more times a week, or is an avid drinker (1 drink defined as 125 mL of wine, 220 mL of beer or 50 mL of liquor; alcoholism defined as 5 or more drinks in approximately 2 hours);

7. Those who smoked more than 10 cigarettes per day during the 3 months prior to screening;

8. Hepatitis B surface antigen (HBsAg), HCV antibodies, syphilis spirochete antibodies and HIV antibody-positive persons;

9. Those with positive drug abuse screening results or alcohol breath test results;

10. Those with positive pregnancy test results(female)；

11. Those who have other factors that the investigator considers unsuitable for participation in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SPH Sine Pharmaceutical Laboratories Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CRC-C2009

Identifier Type: -

Identifier Source: org_study_id