Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

An Open-label, Randomized, Single-dose, Two-period Crossover Design on Evaluating the Bioequivalence of Spironolactone Tablets 100mg (by SPH Sine Pharmaceutical Laboratories Co.,Ltd) and ALDACTONE® Tablets 100mg (by GD SEARLE LLC) in Healthy Adult Volunteers Under Fasting and Fed Conditions

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.

Study Overview

• Status: Completed
• Conditions: Bioequivalence Study
• Intervention / Treatment: Drug: Spironolactone Tablets (Test); Drug: Spironolactone Tablets (Reference)

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test product; Spironolactone Tablets, 100 mg/tablet, to be orally administered.	Drug: Spironolactone Tablets (Test); Take one test tablet each period
Active Comparator: Reference product; ALDACTONE® Tablets,100 mg/tablet, to be orally administered.	Drug: Spironolactone Tablets (Reference); Take one reference tablet each period; Other Names: ALDACTONE® tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum Observed Concentration in Plasma	up to 24 hours after tablet intake
AUC 0-t	Area Under the Concentration-time Curve From Time Zero to Time of Last	up to 24 hours after tablet intake
AUC 0-∞	Area Under the Concentration-time Curve From Time Zero to Infinity	up to 24 hours after tablet intake

Collaborators and Investigators

• Sponsor: SPH Sine Pharmaceutical Laboratories Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): August 23, 2023

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Spironolactone
• Other Study ID Numbers: CRC-C2009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No