Bio-equivalence StudyPhase 1NCT02132897
Fed Bioequivalence Study of CBZ Formulations
A Phase 1 study testing Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose and Tegretol CR 400 Single Dose-Auration CR 400 Single Dose in people with Bio-equivalence Study and Fed Conditions, run by Center for Clinical Pharmacology Research Bdbeq S.A. at 1 site in Uruguay.
Trial summary
Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with time due to metabolism autoinduction. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bio-equivalence Study, Fed Conditions
- What is being tested?
- Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose and Tegretol CR 400 Single Dose-Auration CR 400 Single Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUruguay
- Study dates
- May 2014to Jun 2014
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking or smokers of less than 5 cigarettes/day, within the age range of 18 to 50 years.
- Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 24.9 kg/m2.
- No clinically significant findings in the physical examination, 12-lead electrocardiogram (ECG) and vital signs (blood pressure between 100-140/58-90 mmHg, heart rate between 50-99 beats/min, temperature between 35.8ºC and 37.6ºC, respiration rate between 12 and 20 breaths/minute)
- No clinical laboratory values outside of the acceptable range as per protocol, unless the Principal Investigator or Sub-investigator decides that they are not clinically significant (NCS).
- Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements.
- The subject agrees to abstain from alcohol, coffee and other food and drinks containing methylxanthines (mate, tea, cola, chocolate) for 48hours, and grapefruit containing food and beverages for 72 hours prior study drug administration and during each study period.
Who cannot join
- Known history of hypersensitivity to Carbamazepine and/or related drugs.
- Positive test for hepatitis B surface antigen, hepatitis C or HIV.
- Known history of gastrointestinal (e.g: gastritis, inflammatory bowel disease, celiac disease), cardiac, pulmonary, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies, unless deemed NCS by the Principal Investigator or Sub-investigator.
- Any history of peptic ulcer disease or gastrointestinal (GI) bleeding.
- Any history of gastrointestinal surgery (except for appendectomy).
- Presence of any significant physical or organ abnormality.
Show all 20Show fewer
- Any illness during the 4 weeks before this study, unless deemed NCS by the Clinical Investigator or Sub-investigator.
- Any history or evidence of psychiatric or psychological disease, unless deemed NCS by the Clinical Investigator or Sub-investigator.
- Any history of asthma (after 12 years of age).
- Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
- Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Any history of drug and psychoactive medicines abuse.
- Any recent history of alcohol abuse (less than 1 year).
- Use of any prescription medication within 14 days preceding this study.
- Use of vaccinations within 30 days preceding this study.
- Use of over-the-counter (OTC) medication within the 7 days preceding this study (except for spermicidal/barrier contraceptive products, sunscreen and sunblock products).
- Participation as a plasma donor in a plasmapheresis program within 7 days preceding this study.
- Blood donations within 60 days preceding and after this study.
- Participation in a clinical trial with an investigational drug within 180 days preceding this study, and agreement not to participate in a clinical trial for 180 days after this study.
- Intolerance to venipuncture.
Trial locations and contacts
1 site in 1 country.
Uruguay1 site
Center for Clinical Pharmacology Research Bdbeq S.A. Italian Hospital
Montevideo, Montevideo Department, 11800
About this study
Official title: Fed Bioequivalence Study of Carbamazepine Controlled Release Formulations in Healthy Male Uruguayan Subjects
Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with time due to metabolism autoinduction.
The primary objective of this study is to estimate the bioequivalence of the new brand generic product (Auration(R) CR) 400 mg manufactured in Uruguay vs. the innovative product (Tegretol(R) CR) 400 mg manufactured in Brasil, under fed conditions. The secondary objective will be evaluation of safety issues.
Read more
The study design will be randomized two sequences, two periods and crossover. For a power of not less than 80% sample size was estimated to be 20 healthy male subjects. Products will be administered with food (high calories/high fat breakfast) after an overnight fast.
Time vs. concentration curves will be built for each subject and formulation and Area Under Curve (AUC0240) will be estimated using the trapezoid rule, the AUC 0-inf. (from time 0 to infinity) will be estimated using the formula Cz/Ke, Cmax will be taken from the individual curves.
This parameters will be statistically processed with the WinNonlin 6.3 Pharmacokinetics/Statistic software in order to prove bioequivalence between the study products.
- Conditions
- Bio-equivalence Study, Fed Conditions
- Being tested
- Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose, Tegretol CR 400 Single Dose-Auration CR 400 Single Dose
- Keywords
- Antiepileptic, Carbamazepine, Bio-equivalence, Fed, Crossover
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single DoseDrug
Also called Carbamazepine, Carbamazepine CR, Carbamazepine CR 400 millligrams
Carbamazepine CR Tablets 400 milligrams is given orally with 250 mL of water at room temperature.
Tegretol CR 400 Single Dose-Auration CR 400 Single DoseDrug
Also called Carbamazepine, Carbamazepine CR, Carbamazepine CR 400
Auration CR 400 milligrams Single Dose is given orally with 250 mL of water at room temperature.
| Study group | Role | What they receive |
|---|---|---|
| TR (Test - Reference) | Other | Sequence : Auration CR 400 Single Dose/Tegretol CR 400 Single Dose Receives: Drug: Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose |
| RT (Reference - Test) | Other | Sequence: Tegretol CR 400 Single Dose/Auration CR 400 Single Dose Receives: Drug: Tegretol CR 400 Single Dose-Auration CR 400 Single Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-240
Area Under the CBZ Concentration vs. time curve from sample time point 0 hour to sample time point 240 hour.
Measured: 10 days
AUC0-inf
Area Under the CBZ Concentrations vs, time curve from sample time point 0 hour to sample time point 240 hours plus extrapolation to infinity of the terminal concentration slope.
Measured: 0 to 240 hours
Cmax
The maximum concentration in the CBZ concentrations vs. time curves for each subject and each formulation.
Measured: 12 to 48 hours
Secondary outcomes (1)
AE
Recording of all adverse events (AE) occurring during the study: expected, unexpected and serious (SAE) from tree different sources. The AEs may be clinical occurrences, abnormal labs or ECG alterations.
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bio-equivalence 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Pharmacology Research Bdbeq S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco E. Estevez-Carrizo, M.D., Center for Clinical Pharmacology Research Bdbeq S.A.
- Investigators
- Francisco E. Estevez-Carrizo, M.D., Study director, Center for Clinical Pharmacology Research Bdbeq S.A.Francisco T. Estevez-Parrillo, M.D., Principal investigator, Center for Clinical Pharmacology Research Bdbeq S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132897
- Sponsor's protocol ID
- BDBEQ-CBZ400/EUFUY-023
- Status last verified
- Jun 2014
- First submitted
- 6 May 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fed Bioequivalence Study of Carbamazepine Controlled Release Formulations in Healthy Male Uruguayan Subjects
- ClinicalTrials.gov ID
- NCT02132897
- Acronym / sponsor ID
- BDBEQ-CBZ400/EUFUY-023
- Conditions
- Bio-equivalence Study, Fed Conditions
- Keywords
- Antiepileptic, Carbamazepine, Bio-equivalence, Fed, Crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Center for Clinical Pharmacology Research Bdbeq S.A.University, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 May 2014 (estimated)
- 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.
Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with time due to metabolism autoinduction.
The primary objective of this study is to estimate the bioequivalence of the new brand generic product (Auration(R) CR) 400 mg manufactured in Uruguay vs. the innovative product (Tegretol(R) CR) 400 mg manufactured in Brasil, under fed conditions. The secondary objective will be evaluation of safety issues.
The study design will be randomized two sequences, two periods and crossover. For a power of not less than 80% sample size was estimated to be 20 healthy male subjects. Products will be administered with food (high calories/high fat breakfast) after an overnight fast.
Time vs. concentration curves will be built for each subject and formulation and Area Under Curve (AUC0240) will be estimated using the trapezoid rule, the AUC 0-inf. (from time 0 to infinity) will be estimated using the formula Cz/Ke, Cmax will be taken from the individual curves.
This parameters will be statistically processed with the WinNonlin 6.3 Pharmacokinetics/Statistic software in order to prove bioequivalence between the study products.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR (Test - Reference) | Other | Drug: Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single DoseSequence : Auration CR 400 Single Dose/Tegretol CR 400 Single Dose |
| RT (Reference - Test) | Other | Drug: Tegretol CR 400 Single Dose-Auration CR 400 Single DoseSequence: Tegretol CR 400 Single Dose/Auration CR 400 Single Dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking or smokers of less than 5 cigarettes/day, within the age range of 18 to 50 years.
- Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 24.9 kg/m2.
- No clinically significant findings in the physical examination, 12-lead electrocardiogram (ECG) and vital signs (blood pressure between 100-140/58-90 mmHg, heart rate between 50-99 beats/min, temperature between 35.8ºC and 37.6ºC, respiration rate between 12 and 20 breaths/minute)
- No clinical laboratory values outside of the acceptable range as per protocol, unless the Principal Investigator or Sub-investigator decides that they are not clinically significant (NCS).
- Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements.
Key exclusion criteria (20 listed)
- Known history of hypersensitivity to Carbamazepine and/or related drugs.
- Positive test for hepatitis B surface antigen, hepatitis C or HIV.
- Known history of gastrointestinal (e.g: gastritis, inflammatory bowel disease, celiac disease), cardiac, pulmonary, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies, unless deemed NCS by the Principal Investigator or Sub-investigator.
- Any history of peptic ulcer disease or gastrointestinal (GI) bleeding.
- Any history of gastrointestinal surgery (except for appendectomy).
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 |
|---|---|---|
| Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single DoseAlso: Carbamazepine, Carbamazepine CR, Carbamazepine CR 400 millligramsCarbamazepine CR Tablets 400 milligrams is given orally with 250 mL of water at room temperature. | Drug | TR (Test - Reference) |
| Tegretol CR 400 Single Dose-Auration CR 400 Single DoseAlso: Carbamazepine, Carbamazepine CR, Carbamazepine CR 400Auration CR 400 milligrams Single Dose is given orally with 250 mL of water at room temperature. | Drug | RT (Reference - Test) |
Primary outcome
AUC0-240
Time frame: 10 days
Area Under the CBZ Concentration vs. time curve from sample time point 0 hour to sample time point 240 hour.
AUC0-inf
Time frame: 0 to 240 hours
Area Under the CBZ Concentrations vs, time curve from sample time point 0 hour to sample time point 240 hours plus extrapolation to infinity of the terminal concentration slope.
Cmax
Time frame: 12 to 48 hours
The maximum concentration in the CBZ concentrations vs. time curves for each subject and each formulation.
1 secondary outcome
AE
Time frame: 31 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 17 Jun 2014.
Related trials for Bio-equivalence Study
Enrolling by invitation
BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation
DFU, VLU
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.
Francisco E. Estevez-Carrizo, M.D. study director
Center for Clinical Pharmacology Research Bdbeq S.A.
Francisco T. Estevez-Parrillo, M.D. principal investigator
Center for Clinical Pharmacology Research Bdbeq S.A.
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 Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose and Tegretol CR 400 Single Dose-Auration CR 400 Single Dose in people with Bio-equivalence Study and Fed Conditions, run by Center for Clinical Pharmacology Research Bdbeq S.A. at 1 site in Uruguay.
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 20 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 17 Jun 2014. 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 Uruguay. 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?
AUC0-240 (time frame: 10 days). 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 17 Jun 2014.