BioequivalencePhase 1NCT03799536
Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions
A Phase 1 study testing Sotalol and Sotalex in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Belarus.
Trial summary
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Sotalol and Sotalex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelarus
- Study dates
- 9 Jan 2019to 11 Feb 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian men or women aged between 18 to 55 years
- Body mass index 18.5-30 kg/m²
- Subjects who have no signs of disease during the screening, and whose screening is conducted within 21 days after the registration in the trial
- Subjects whose laboratory blood and urine values are within the normal range orof deviations are considered by researchers to be clinically insignificant
- Non-smokers or ex-smokers (defined as completely quitting smoking for at least three months prior to being included in the test)
- No known history of alcohol abuse
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- No known history of abuse of drugs (benzodiazepines, opioids, cocaine, barbiturates, amphetamine, etc.)
- Willingness to comply with the protocol requirements regarding the restriction of the consumption of products containing xanthine (coffee, tea, chocolate, cola, etc.) for at least 48 hours and products containing tobacco, alcohol-containing products and beverages, grapefruit and/or its juice, food containing poppy at least 72 hours prior taking the investigational medicinal products and over the course of the study, as well as requirements regarding the intake of food, fluids and physical activity imposed by the study
- Healthy subject according to medical history, physical examination and assessment of basic vital signs
- No significant abnormalities on 12-lead ECG
- No significant abnormalities on the chest x-ray obtained within 12 months prior the start of the study
- Consent of women of childbearing age and male participants to use medically confirmed barrier methods of contraception (from the date of screening to the completion of the study), or surgical sterilization in history, or women in postmenopause (at least 24 months) or hysterectomy in history . If women use hormonal contraceptives,they should stop them at least 60 days prior the planned beginning of the study
- The subject's voluntary willingness to provide written informed consent
- The ability, at disceretion of the researcher, to follow all the requirements of the protocol
- The ability, at judgment of the researcher, to follow all the requirements of the protocol
Who cannot join
- Known history of allergy
- Known contraindications to the use of investigational products or hypersensitivity to the active substance or components of drugs
- Use of drugs with enzymatic-modifying activity, within 28 days prior the beginning of the study
- Use any over-the-counter or prescription drugs (including vitamins, minerals, herbal remedies, and dietary supplements) within 14 days prior the administration of investigational products and over the course of the study
- Intense physical exercises within 24 hours prior to the administration of investigational products
- Any medical or surgical interventions that can disrupt the function of the hematopoietic system, the gastrointestinal tract (with the exception of appendectomy), the liver, urinary system and other body systems
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- Any chronic diseases or conditions of the urinary, cardiovascular, neuroendocrine, immune, central nervous systems, hematopoietic system, gastrointestinal tract, liver, organs of vision and other systems of the body and diabetes in medical history, mental illness in an active phase or the history
- The presence of any hereditary disease
- Participation in any clinical trials within 90 days prior the beginning of the current clincial study
- Oncological diseaes in medical history
- Any blood donation within 90 days prior the beginning of the current clincial study
- Acute infectious diseases within 28 days prior the beginning of the current clincial study as well as positive testing for HIV, hepatitis B and C, and syphilis
- Positive test for alcohol
- Positive urinary screen test for drugs of abuse
- Swallowing problems in mediical history
- Positive urinary pregnancy test
- Breast-feeding
- Known history of venous access difficulties
- Vegetarian diet
- Sitting systolic blood pressure < 110 mm Hg or > 140 mm Hg and/or sitting diastolic blood pressure < 70 mm Hg or > 90 mm Hg.Heart rate <50 or >100 beats per minute at screening check-in
- Values of the standard laboratory and instrumental tests outside of normal limits and are judged as clinically significant by investigators or require additional examination and interpretation.
Trial locations and contacts
1 site in 1 country.
Belarus1 site
National Anti-Doping Laboratory
Settl.Lesnoy, Minsk Oblast, 223040
About this study
Official title: Open-label, Randomized, Crossover, Two-period, Two-sequence Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex®, Tablets, 160 mg (BRISTOL-MYERS SQUIBB GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Condition
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.The study was conducted in multiple groups.
Read the detailed description
The objective of this study is to establish if two formulations of sotalol are bioequivalent. The test formulation is Sotalol Tablets, 160 mg (Pharmtechnology LLC, Belarus). The reference formulation is Sotalex®, Tablets, 160 mg (Bristol-Myers Squibb GmbH \& Co. KGaA, Germany). 36 healthy adult volunteers of both genders with age ranging from 18 to 55 years old will receive a single tablet (160 mg of sotalol) of the test and the reference products with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list. In the first period, 18 subjects will receive the test product and 18 subjects the reference product.In the second period subjects will receive the products in the opposite order. Subjects will fast 4 hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples were collected before dosing and 0,5 ; 1; 1,5; 2 ; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing (total number: 19). The washout period will be 14 days. A validated HPLC/MS/MS method will be used to determine plasma concentrations of analyte (sotalol). ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for the analyte, both falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t.
- Conditions
- Bioequivalence
- Being tested
- Sotalol, Sotalex
- Keywords
- Bioequivalence, Sotalol, Sotalex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotalolDrug
Also called the test product
Sotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus
SotalexDrug
Also called the reference product
Sotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH \& Co. KGaA, Germany
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | Subjects assigned to sequence AB will receive a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 1 and a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Sotalol |
| Sequence BA | Active comparator | Subjects assigned to sequence BA will receive a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 1 and a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Sotalex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of sotalol for the test and the reference products
Maximum concentration in plasma among observed concentrations at pre-specified time points
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
AUC0-t of sotalol for the test and the reference products
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Secondary outcomes (6)
AUC0-∞ of sotalol for the test and the reference products
Area under the plasma concentration versus time curve from time 0 to to infinite time
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Tmax of sotalol for the test and the reference products
Time to maximum measured plasma concentration
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
T1/2 of sotalol for the test and the reference products
Elimination or terminal half-life
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Kel of sotalol for the test and the reference products
Elimination rate constant
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
AUCresid of sotalol for the test and the reference products
Residual area
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
An AE is defined as any untoward medical occurrence in a subject administered an investigational product and which does not necessarily have a causal relationship with the treatment. The data from participants who had taken at least one investigational product was analyzed.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start9 Jan 2019
- Primary completion4 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Anti-Doping Labaratory
- Responsible party
- Sponsor
- Investigators
- Anastasia Teteryukova, MD, Principal investigator, National Anti-Doping Labaratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799536
- Sponsor's protocol ID
- BE-SOTL-160- 2018
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Company may provide the individual participant data after privacy protection on the case by case basis
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Crossover, Two-period, Two-sequence Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex®, Tablets, 160 mg (BRISTOL-MYERS SQUIBB GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Condition
- ClinicalTrials.gov ID
- NCT03799536
- Acronym / sponsor ID
- BE-SOTL-160- 2018
- Conditions
- Bioequivalence
- Keywords
- Bioequivalence, Sotalol, Sotalex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Anti-Doping Labaratory
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 10 Jan 2019 (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.
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.The study was conducted in multiple groups.
Detailed description
The objective of this study is to establish if two formulations of sotalol are bioequivalent. The test formulation is Sotalol Tablets, 160 mg (Pharmtechnology LLC, Belarus). The reference formulation is Sotalex®, Tablets, 160 mg (Bristol-Myers Squibb GmbH \& Co. KGaA, Germany). 36 healthy adult volunteers of both genders with age ranging from 18 to 55 years old will receive a single tablet (160 mg of sotalol) of the test and the reference products with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list. In the first period, 18 subjects will receive the test product and 18 subjects the reference product.In the second period subjects will receive the products in the opposite order. Subjects will fast 4 hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples were collected before dosing and 0,5 ; 1; 1,5; 2 ; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing (total number: 19). The washout period will be 14 days. A validated HPLC/MS/MS method will be used to determine plasma concentrations of analyte (sotalol). ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for the analyte, both falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Drug: SotalolSubjects assigned to sequence AB will receive a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 1 and a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence BA | Active comparator | Drug: SotalexSubjects assigned to sequence BA will receive a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 1 and a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Caucasian men or women aged between 18 to 55 years
- Body mass index 18.5-30 kg/m²
- Subjects who have no signs of disease during the screening, and whose screening is conducted within 21 days after the registration in the trial
- Subjects whose laboratory blood and urine values are within the normal range orof deviations are considered by researchers to be clinically insignificant
- Non-smokers or ex-smokers (defined as completely quitting smoking for at least three months prior to being included in the test)
Key exclusion criteria (21 listed)
- Known history of allergy
- Known contraindications to the use of investigational products or hypersensitivity to the active substance or components of drugs
- Use of drugs with enzymatic-modifying activity, within 28 days prior the beginning of the study
- Use any over-the-counter or prescription drugs (including vitamins, minerals, herbal remedies, and dietary supplements) within 14 days prior the administration of investigational products and over the course of the study
- Intense physical exercises within 24 hours prior to the administration of investigational products
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 |
|---|---|---|
| SotalolAlso: the test productSotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus | Drug | Sequence AB |
| SotalexAlso: the reference productSotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH \& Co. KGaA, Germany | Drug | Sequence BA |
Primary outcome
Cmax of sotalol for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-t of sotalol for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
6 secondary outcomes
AUC0-∞ of sotalol for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Tmax of sotalol for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
T1/2 of sotalol for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Kel of sotalol for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
AUCresid of sotalol for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
Time frame: 28 days
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 7 Jun 2019.
- Individual participant dataSharing planned: Undecided. The Company may provide the individual participant data after privacy protection on the case by case basis
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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.
Anastasia Teteryukova, MD principal investigator
National Anti-Doping Labaratory
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 Sotalol and Sotalex in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Belarus.
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 15 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 7 Jun 2019. 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 Belarus. 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 of sotalol for the test and the reference products (time frame: Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing). 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 7 Jun 2019.