Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

NCT06579053 | Completed Phase 1

• 1 other identifier: CRC-C2009
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Test product

EXPERIMENTAL

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

Drug: Spironolactone Tablets (Test)

Reference product

ACTIVE COMPARATOR

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

Drug: Spironolactone Tablets (Reference)

Interventions

Spironolactone Tablets (Test) DRUG

Take one test tablet each period

Test product

Spironolactone Tablets (Reference) DRUG

Take one reference tablet each period

Also known as: ALDACTONE® tablets

Reference product

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old ≤ age ≤ 40 years old, male or female;
• 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);
• 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;
• 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;
• No parenting plan and access to reliable contraception during the trial and within 3 months of the last dose;
• 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.

You may not qualify if:

• Persons with a known history of allergy, allergic disorder or hypersensitivity to the test product and any of its components or related agents;
• 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.);
• Those who have donated blood or lost ≥ 400 mL of blood within 3 months prior to enrollment;
• Those who have taken any medication within 2 weeks prior to screening;
• Those who have participated in other drug clinical trials within 3 months prior to enrollment;
• 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);
• Those who smoked more than 10 cigarettes per day during the 3 months prior to screening;
• Hepatitis B surface antigen (HBsAg), HCV antibodies, syphilis spirochete antibodies and HIV antibody-positive persons;
• Those with positive drug abuse screening results or alcohol breath test results;
• Those with positive pregnancy test results(female)；
• Those who have other factors that the investigator considers unsuitable for participation in the trial.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: March 22, 2023
• Primary Completion: May 5, 2023
• Study Completion: August 23, 2023
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)