CompletedPhase 1

Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

China64 participantsStarted 2023-03-22

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax

Timeframe: up to 24 hours after tablet intake

AUC 0-t

Timeframe: up to 24 hours after tablet intake

AUC 0-∞

Timeframe: up to 24 hours after tablet intake

Trial details

NCT IDNCT06579053

SponsorSPH Sine Pharmaceutical Laboratories Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-05

View on ClinicalTrials.gov More Bioequivalence Study trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 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.

Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria