Food-drug InteractionPhase 1NCT06211283
Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects.
A Phase 1 study testing Sodium valproate in people with Food-drug Interaction, run by Desitin Arzneimittel GmbH at 1 site in Canada.
Trial summary
to evaluate the comparative bioavailability of valproate from Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Food-drug Interaction
- What is being tested?
- Sodium valproate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 11 Sep 2023to 1 Nov 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking (from at least 6 months prior to study drug administration), male volunteers, 18-65 years of age, inclusive.
- BMI that was within 18.5 and 30.0 kg/m², inclusive.
- Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
- Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
- Clinical laboratory values within BPSI's most recent acceptable laboratory test range, and/or values were deemed by the PI/Sub-Investigator as "Not Clinically Significant".
- Ability to comprehend and be informed of the nature of the study, as assessed by BPSI staff. Capable of giving written informed consent prior to any study- related procedure. Must have been to communicate effectively with clinic staff.
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- Ability to fast for at least 10 hours and consume a high-fat, high-calorie meal, as well as standard meals.
- Ability to fast for at least 14 hours and consume standard meals.
- Availability to volunteer for the entire study duration and was to adhere to all protocol requirements.
- Agreed not to have a tattoo or body piercing until the end of the study.
- Agreed not to receive the COVID-19 vaccination from 7 days prior to the first study drug dose until 7 days after the last study drug administration in the study.
- Agreed not to drive or operate heavy machinery if feeling dizzy or drowsy following study drug administration until full mental alertness was regained.
- Males who were to father children agreed to use medically acceptable methods of contraception and to not donate sperm during the study and for 60 days after the last study drug administration.
- Medically acceptable methods of contraception included using a condom with a female partner of child-bearing potential who was using oral contraceptives, hormonal patch, implant or injection, intrauterine device, or diaphragm with spermicide. Abstinence as a method of contraception is acceptable if it was in line with the preferred and usual lifestyle of the study participant.
- If a subject's partner became pregnant during his participation in the study and for 60 days after he has completed his last study drug administration, he must have informed BPSI staff immediately.
Who cannot join
- Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the PI/Sub-Investigator.
- Estimated creatinine clearance <70 ml/min.
- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
- Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
- A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), breath alcohol test and cotinine.
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- Known history or presence of:
- Alcohol abuse or dependence within one year prior to first study drug administration;
- Drug abuse or dependence;
- Hypersensitivity or idiosyncratic reaction to Orfiril Long, its excipients, and/or related substances;
- Suicidal ideation or suicidal behavior, as assessed by the Columbia Suicide Severity Rating Scale (baseline version) - Appendix C (Refer to Appendix 16.1.1)
- Lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
- Food allergies;
- Presence of any dietary restrictions unless deemed by the PI/Sub-I as "Not Clinically Significant".
- Family history of hereditary neurometabolic syndromes due to mitochondrial enzyme polymerase;
- Known urea cycle disorder;
- Known porphyria;
- Coagulation disorder;
- Family history of liver disease;
- Severe allergic reactions (e.g., anaphylactic reactions, angioedema).
- Intolerance to and/or difficulty with blood sampling through venipuncture.
- Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets etc.
- Individuals who have donated, in the days prior to first study drug administration:
- 50-499 mL of blood in the previous 30 days;
- 500 mL or more in the previous 56 days.
- Donated plasma by plasmapheresis within 7 days prior to first study drug administration.
- Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study drug administration.
- Use of any enzyme-modifying drugs and/or other products, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John´s Wort, and rifampicin) in the previous 30 days before first study drug administration.
- Used of any monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) within 30 days prior to first study drug administration.
- Used of any prescription medication within 14 days prior to first study drug administration.
- Used of any over-the-counter medications (including oral multivitamins, herbal and/or dietary supplements) within 14 days prior to first study drug administration.
- Consumed food or beverages containing grapefruit and/or pomelo within 10 days prior to first study drug administration.
- Consumed food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing in each study period.
- Individuals who had undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by PI/Sub-Investigator.
- Difficulty with swallowing whole tablets.
- Unable or unwilling to provide informed consent.
- Had a tattoo or body piercing within 30 days prior to first study drug administration.
- A subject who, in the opinion of the investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose, Open-label, Four-way, Fed-fasted Crossover, Comparative Bioavailability and Food Effect of Orfiril Long 500 mg Prolonged Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets in Healthy Male Subjects.
to evaluate the comparative bioavailability of valproate from Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting and fed conditions.
Read the detailed description
This was a pivotal, single dose, randomized, open-label, four-period, four-sequence, four-treatment, single-centre, four-way crossover design, food effect and comparative bioavailability study of Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, non-smoking, male subjects under fasting and fed conditions. Subjects were randomly assigned to one of the four dosing sequences.
- Conditions
- Food-drug Interaction
- Being tested
- Sodium valproate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium valproateDrug
Also called Orfiril long 500 Mg Prolonged Release Oral Tablet
fasted
Sodium valproateDrug
Also called Orfiril long 500 Mg Prolonged Release Oral Tablet
fed
| Study group | Role | What they receive |
|---|---|---|
| Treatment A, Orfiril long, 500 mg prolonged release minitablets | Experimental | fasting Receives: Drug: Sodium valproate |
| Treatment B, Orfiril long, 500 mg prolonged release minitablets | Experimental | fed Receives: Drug: Sodium valproate |
| Treatment C, Ergenyl chrono 500 mg prolonged release tablets | Active comparator | fasting Receives: Drug: Sodium valproate |
| Treatment D, Ergenyl chrono 500 mg prolonged release tablets | Active comparator | fed Receives: Drug: Sodium valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC), fasted state
to establish bioequivalence, the calculated 90% CI for the ratio of geometric means for AUC for valproate should fall within 80.00% - 125.00%.
Measured: PK sampling - Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 24, 36, 48, and 60 hours post-dose in each period.
Cmax, fasted state
to establish bioequivalence, the calculated 90% CI for the ratio of geometric means for Cmax for valproate should fall within 80.00% - 125.00%.
Measured: PK sampling - Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 24, 36, 48, and 60 hours post-dose in each period.
Secondary outcomes (2)
Area under the curve (AUC) fed state
to assess the food effect (fasting vs high-fat conditions) on the AUC of valproate plasma concentration
Measured: PK sampling - Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 24, 36, 48, and 60 hours post-dose in each period.
Cmax, fed state
to assess the food effect (fasting vs high-fat conditions) on the Cmax of valproate plasma concentration
Measured: PK sampling - Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 24, 36, 48, and 60 hours post-dose in each period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start11 Sep 2023
- Primary completion20 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food-drug InteractionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desitin Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioPharma Services Inc.
- Responsible party
- Sponsor
- Investigators
- Janice Faulknor, MD, Principal investigator, BioPharma Services Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211283
- Sponsor's protocol ID
- VPA-055/K
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose, Open-label, Four-way, Fed-fasted Crossover, Comparative Bioavailability and Food Effect of Orfiril Long 500 mg Prolonged Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT06211283
- Acronym / sponsor ID
- VPA-055/K
- Conditions
- Food-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Desitin Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Collaborators
- BioPharma Services Inc.
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Jan 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.
to evaluate the comparative bioavailability of valproate from Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting and fed conditions.
Detailed description
This was a pivotal, single dose, randomized, open-label, four-period, four-sequence, four-treatment, single-centre, four-way crossover design, food effect and comparative bioavailability study of Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, non-smoking, male subjects under fasting and fed conditions. Subjects were randomly assigned to one of the four dosing sequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A, Orfiril long, 500 mg prolonged release minitablets | Experimental | Drug: Sodium valproatefasting |
| Treatment B, Orfiril long, 500 mg prolonged release minitablets | Experimental | Drug: Sodium valproatefed |
| Treatment C, Ergenyl chrono 500 mg prolonged release tablets | Active comparator | Drug: Sodium valproatefasting |
| Treatment D, Ergenyl chrono 500 mg prolonged release tablets | Active comparator | Drug: Sodium valproatefed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy, non-smoking (from at least 6 months prior to study drug administration), male volunteers, 18-65 years of age, inclusive.
- BMI that was within 18.5 and 30.0 kg/m², inclusive.
- Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
- Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
- Clinical laboratory values within BPSI's most recent acceptable laboratory test range, and/or values were deemed by the PI/Sub-Investigator as "Not Clinically Significant".
Key exclusion criteria (38 listed)
- Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the PI/Sub-Investigator.
- Estimated creatinine clearance <70 ml/min.
- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
- Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
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 |
|---|---|---|
| Sodium valproateAlso: Orfiril long 500 Mg Prolonged Release Oral Tabletfasted | Drug | Treatment A, Orfiril long, 500 mg prolonged release minitablets, Treatment B, Orfiril long, 500 mg prolonged release minitablets, Treatment C, Ergenyl chrono 500 mg prolonged release tablets, Treatment D, Ergenyl chrono 500 mg prolonged release tablets |
| Sodium valproateAlso: Orfiril long 500 Mg Prolonged Release Oral Tabletfed | Drug | Treatment A, Orfiril long, 500 mg prolonged release minitablets, Treatment B, Orfiril long, 500 mg prolonged release minitablets, Treatment C, Ergenyl chrono 500 mg prolonged release tablets, Treatment D, Ergenyl chrono 500 mg prolonged release tablets |
Primary outcome
Area under the curve (AUC), fasted state
Time frame: PK sampling - Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 24, 36, 48, and 60 hours post-dose in each period.
to establish bioequivalence, the calculated 90% CI for the ratio of geometric means for AUC for valproate should fall within 80.00% - 125.00%.
Cmax, fasted state
Time frame: PK sampling - Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 24, 36, 48, and 60 hours post-dose in each period.
to establish bioequivalence, the calculated 90% CI for the ratio of geometric means for Cmax for valproate should fall within 80.00% - 125.00%.
2 secondary outcomes
Area under the curve (AUC) fed state
Time frame: PK sampling - Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 24, 36, 48, and 60 hours post-dose in each period.
Cmax, fed state
Time frame: PK sampling - Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 24, 36, 48, and 60 hours post-dose in each period.
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 22 Jan 2024.
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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.
Janice Faulknor, MD principal investigator
BioPharma Services Inc.
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 Sodium valproate in people with Food-drug Interaction, run by Desitin Arzneimittel GmbH at 1 site in Canada.
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 38 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 22 Jan 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 Canada. 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?
Area under the curve (AUC), fasted state (time frame: PK sampling - Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 24, 36, 48, and 60 hours post-dose in each period.). 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 22 Jan 2024.