Bioequivalence StudyPhase 1NCT06579053
Bioequivalence Study of Spironolactone Tablets in Healthy Subjects
A Phase 1 study testing Spironolactone Tablets (Test) and Spironolactone Tablets (Reference) in people with Bioequivalence Study, run by SPH Sine Pharmaceutical Laboratories Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study
- What is being tested?
- Spironolactone Tablets (Test) and Spironolactone Tablets (Reference)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2023to 23 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: 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.
- Conditions
- Bioequivalence Study
- Being tested
- Spironolactone Tablets (Test), Spironolactone Tablets (Reference)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone Tablets (Test)Drug
Take one test tablet each period
Spironolactone Tablets (Reference)Drug
Also called ALDACTONE® tablets
Take one reference tablet each period
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Spironolactone Tablets, 100 mg/tablet, to be orally administered. Receives: Drug: Spironolactone Tablets (Test) |
| Reference product | Active comparator | ALDACTONE® Tablets,100 mg/tablet, to be orally administered. Receives: Drug: Spironolactone Tablets (Reference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Concentration in Plasma
Measured: up to 24 hours after tablet intake
AUC 0-t
Area Under the Concentration-time Curve From Time Zero to Time of Last
Measured: up to 24 hours after tablet intake
AUC 0-∞
Area Under the Concentration-time Curve From Time Zero to Infinity
Measured: up to 24 hours after tablet intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start22 Mar 2023
- Primary completion5 May 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPH Sine Pharmaceutical Laboratories Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579053
- Sponsor's protocol ID
- CRC-C2009
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06579053
- Acronym / sponsor ID
- CRC-C2009
- Conditions
- Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- SPH Sine Pharmaceutical Laboratories Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: Spironolactone Tablets (Test)Spironolactone Tablets, 100 mg/tablet, to be orally administered. |
| Reference product | Active comparator | Drug: Spironolactone Tablets (Reference)ALDACTONE® Tablets,100 mg/tablet, to be orally administered. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone Tablets (Test)Take one test tablet each period | Drug | Test product |
| Spironolactone Tablets (Reference)Also: ALDACTONE® tabletsTake one reference tablet each period | Drug | Reference product |
Primary outcome
Cmax
Time frame: up to 24 hours after tablet intake
Maximum Observed Concentration in Plasma
AUC 0-t
Time frame: up to 24 hours after tablet intake
Area Under the Concentration-time Curve From Time Zero to Time of Last
AUC 0-∞
Time frame: up to 24 hours after tablet intake
Area Under the Concentration-time Curve From Time Zero to Infinity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spironolactone Tablets (Test) and Spironolactone Tablets (Reference) in people with Bioequivalence Study, run by SPH Sine Pharmaceutical Laboratories Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: up to 24 hours after tablet intake). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.