Heart FailurePhase 1NCT06546215
Bioequivalence Study of Digoxin Tablet in Healthy Subjects
A Phase 1 study testing Digoxin in people with Heart Failure, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The study followed an open-label, randomized, single-dose (0.25mg), four-period full-replicate design encompassing both fasted and fed conditions. Subjects were randomized into two sequences, labeled as group A (TRTR) and group B (RTRT), for the four sessions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2020to 23 Jan 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Chinese adults aged no less than 18 years
- A body mass index (BMI) falling within the range of 19.0 to 26.0 kg/m2, and a body weight of no less than 45kg for females and 50kg for males respectively.
- All participants signed the informed consent form after receiving thorough information about the study protocol and agreed to adhere to it.
Who cannot join
- Allergic to digoxin tablets and other digitalis preparations, or allergic to two or more drugs (or foods);
- Subjects cannot follow a uniform diet ;
- Subjects cannot tolerate venipuncture or have a history of dizziness with needles or blood;
- Subjects with medical history of cardiovascular (e.g., ventricular fibrillation, sinus node block), liver, kidney, endocrine, digestive tract, hematological, respiratory, malignant tumor, mental disorder, or any of the above diseases judged by the investigators as clinically significant;
- Subjects underwent major surgical procedures within 6 months before screening or planned to undergo surgery during the study, and those who underwent surgery affecting drug absorption, distribution, metabolism, or excretion (except appendicitis surgery);
- Screening stage of physical examination, vital signs measurement, cardiogram, heart color to exceed, whole chest is slice examination, laboratory examination, blood routine, routine urine and blood biochemistry, blood coagulation function, thyroid function, blood/urine pregnancy (only female subjects), etc.), the researchers determine abnormal have clinical significance;
Show all 21Show fewer
- Creatinine clearance rate (Ccr) that is beyond the scope of 80 ~ 120 ml/min (including boundary value);
- Clinically significant abnormal results of hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, or human immunodeficiency virus antibody;
- Long-term (within 3 months before screening) excessive consumption (more than 8 cups per day, 1 cup =200mL) of tea, coffee, or caffeinated beverages; Or consuming any food or beverage (e.g., coffee, strong tea, chocolate, etc.) containing caffeine within 48 hours before the first dose of study medication;
- Consuming any beverage or food containing grapefruit or other substances affecting drug absorption, distribution, metabolism, excretion, etc., within 48 hours before the first dose of medication;
- Use of any medication known to interact with digoxin tablets within 4 weeks before screening;
- Patients who used long-acting estrogen or progestin injection or implant within 6 months before the trial; Use of short-acting contraceptives within 30 days before the trial;
- Subjects who had used any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements within 14 days before the first study medication;
- 3 months before the screening of daily smoking more than 5 pieces, and chosen to the whole experiments cannot accept ban smokers;
- Positive alcohol breath test before first medication use or had consumed more than 14 standard units (SD) per week (1 SD containing 14g of alcohol) in the 6 months prior to screening;
- Subjects who were positive in drug screening before the first drug use or had a history of drug abuse within 1 year before the test;
- Pregnant or lactating women, and male (or their partner) or female subjects who plan to become pregnant throughout the trial and within 3 months after the end of the study;
- Female subjects who had unprotected sex within 14 days before screening;
- Subjects who participated in another clinical trial and took drugs within 3 months before the first dose of the study drug;
- Subjects donating blood or blood loss ≥400mL within 3 months before the first dose of study medication, or planning to donate blood or blood components during the study or within 3 months after the end of the study;
- The investigator believes that any circumstances may affect the provision of informed consent or compliance with the trial protocol, or that the participant's participation in the trial may affect the trial results or their safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose (0.25mg), Four-period Fully Replicated Bioequivalence Study of Digoxin Tablet Under Fasted and Fed Conditions in Healthy Subjects
The study followed an open-label, randomized, single-dose (0.25mg), four-period full-replicate design encompassing both fasted and fed conditions. Subjects were randomized into two sequences, labeled as group A (TRTR) and group B (RTRT), for the four sessions. By the use of a random table produced by SAS statistical software, the individuals were assigned at random to administer a single-dose (0.25mg) of either the reference or the test formulation of digoxin tablets. During the fasted study phase, participants were randomly administered digoxin tablets after an overnight fast of a minimum of 10 hours, and fasting continued for 4 hours post dose. During the fed trial, subjects consumed a high-fat breakfast 30 minutes before administering digoxin tablets, which consisted of approximately 500 to 600 kcal of fat, 150 kcal of protein, and 250 kcal of carbohydrates, totaling around 800 to 1000 kcal calories. The breakfast must be finished within 30 minutes. Digoxin tablets were administered to each subject in a single dosage with 240 mL of water. Each subject was assigned equitably and at random to one of the two groups. A 14-day washout period was implemented between each period. In the fasted study, blood samples were collected at various time points: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours after dosing. Similarly, in the fed study, blood samples were collected at predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours after dosing. Following collection, the samples underwent centrifugation at 1700g for 10 minutes at 4℃. The resulting supernatant was then divided into two aliquots and stored at -80℃ until further analysis was conducted. A validated high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method was employed to assess the level of digoxin in plasma samples. The PK analysis of the plasma concentration-time curve was performed using a non-compartmental modeling method with Phoenix WinNonlin software version 8.2.
- Conditions
- Heart Failure
- Being tested
- Digoxin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigoxinDrug
Administer a single-dose (0.25mg) of either the reference or the test formulation of digoxin tablets.
| Study group | Role | What they receive |
|---|---|---|
| digoxin test drug | Experimental | digoxin tablet, 0.25mg, single dose Receives: Drug: Digoxin |
| digoxin reference drug | Active comparator | digoxin tablet, 0.25mg, single dose Receives: Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration in fasted study.
plasma concentration-time curve
Measured: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours
plasma concentration in fed study.
plasma concentration in fasted study.
Measured: predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start5 Jul 2020
- Primary completion23 Jan 2021
- Study completion23 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pingsheng Xu, Doctor, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546215
- Sponsor's protocol ID
- BTINT024-BE-01
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose (0.25mg), Four-period Fully Replicated Bioequivalence Study of Digoxin Tablet Under Fasted and Fed Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06546215
- Acronym / sponsor ID
- BTINT024-BE-01
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 5 Jul 2020 (actual)
- Primary completion
- 23 Jan 2021 (actual)
- Study completion
- 23 Jan 2021 (actual)
- First posted
- 9 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 study followed an open-label, randomized, single-dose (0.25mg), four-period full-replicate design encompassing both fasted and fed conditions. Subjects were randomized into two sequences, labeled as group A (TRTR) and group B (RTRT), for the four sessions. By the use of a random table produced by SAS statistical software, the individuals were assigned at random to administer a single-dose (0.25mg) of either the reference or the test formulation of digoxin tablets. During the fasted study phase, participants were randomly administered digoxin tablets after an overnight fast of a minimum of 10 hours, and fasting continued for 4 hours post dose. During the fed trial, subjects consumed a high-fat breakfast 30 minutes before administering digoxin tablets, which consisted of approximately 500 to 600 kcal of fat, 150 kcal of protein, and 250 kcal of carbohydrates, totaling around 800 to 1000 kcal calories. The breakfast must be finished within 30 minutes. Digoxin tablets were administered to each subject in a single dosage with 240 mL of water. Each subject was assigned equitably and at random to one of the two groups. A 14-day washout period was implemented between each period. In the fasted study, blood samples were collected at various time points: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours after dosing. Similarly, in the fed study, blood samples were collected at predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours after dosing. Following collection, the samples underwent centrifugation at 1700g for 10 minutes at 4℃. The resulting supernatant was then divided into two aliquots and stored at -80℃ until further analysis was conducted. A validated high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method was employed to assess the level of digoxin in plasma samples. The PK analysis of the plasma concentration-time curve was performed using a non-compartmental modeling method with Phoenix WinNonlin software version 8.2.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digoxin test drug | Experimental | Drug: Digoxindigoxin tablet, 0.25mg, single dose |
| digoxin reference drug | Active comparator | Drug: Digoxindigoxin tablet, 0.25mg, single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Chinese adults aged no less than 18 years
- A body mass index (BMI) falling within the range of 19.0 to 26.0 kg/m2, and a body weight of no less than 45kg for females and 50kg for males respectively.
- All participants signed the informed consent form after receiving thorough information about the study protocol and agreed to adhere to it.
Key exclusion criteria (21 listed)
- Allergic to digoxin tablets and other digitalis preparations, or allergic to two or more drugs (or foods);
- Subjects cannot follow a uniform diet ;
- Subjects cannot tolerate venipuncture or have a history of dizziness with needles or blood;
- Subjects with medical history of cardiovascular (e.g., ventricular fibrillation, sinus node block), liver, kidney, endocrine, digestive tract, hematological, respiratory, malignant tumor, mental disorder, or any of the above diseases judged by the investigators as clinically significant;
- Subjects underwent major surgical procedures within 6 months before screening or planned to undergo surgery during the study, and those who underwent surgery affecting drug absorption, distribution, metabolism, or excretion (except appendicitis surgery);
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 |
|---|---|---|
| DigoxinAdminister a single-dose (0.25mg) of either the reference or the test formulation of digoxin tablets. | Drug | digoxin reference drug, digoxin test drug |
Primary outcome
plasma concentration in fasted study.
Time frame: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours
plasma concentration-time curve
plasma concentration in fed study.
Time frame: predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours
plasma concentration in fasted study.
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 9 Aug 2024.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Pingsheng Xu, Doctor principal investigator
Xiangya Hospital of Central South University
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 Digoxin in people with Heart Failure, run by Xiangya Hospital of Central South University 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 3 inclusion and 21 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 9 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?
plasma concentration in fasted study. (time frame: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours). The study lists 2 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 9 Aug 2024.