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Multiple Drug UsePhase 1NCT06214130

Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets

A Phase 1 study testing Sodium valproate 500 MG and Valproic Acid 500 MG in people with Multiple Drug Use, run by Desitin Arzneimittel GmbH at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comparative bioavailability of valproate from Orfiril long 500 mg prolonged-release mini-tablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting 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
Multiple Drug Use
What is being tested?
Sodium valproate 500 MG and Valproic Acid 500 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
22 Sep 2023to 18 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 between 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 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 able to father children must agree 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 include 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.
  • 2. 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.
  • 3. Estimated creatinine clearance <70 ml/min. 4. Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
  • 5. Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
  • 6. 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.
  • 7. Known history or presence of:
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  • 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 B (Refer to Appendix 16.1.1)
  • 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;
  • Family history of liver disease;
  • Known urea cycle disorder;
  • Known porphyria;
  • Coagulation disorder;
  • Severe allergic reactions (e.g., anaphylactic reactions, angioedema). 8. Intolerance to and/or difficulty with blood sampling through venipuncture. 9. Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets etc.
  • 10. 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. 11. Donated plasma by plasmapheresis within 7 days prior to first study drug administration.
  • 12. Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study drug administration.
  • 13. 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.
  • 14. Used of any monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) within 30 days prior to first study drug administration.
  • 15. Used of any prescription medication within 14 days prior to first study drug administration.
  • 16. Used of any over-the-counter medications (including oral multivitamins, herbal and/or dietary supplements) within 14 days prior to first study drug administration.
  • 17. Consumed food or beverages containing grapefruit and/or pomelo within 10 days prior to first study drug administration.
  • 18. Consumed food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing in each study period.
  • 19. Individuals who had undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by PI/Sub-Investigator.
  • 20. Difficulty with swallowing whole tablets. 21. Unable or unwilling to provide informed consent. 22. Had a tattoo or body piercing within 30 days prior to first study drug administration.
  • 23. 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.

Canada1 site

  • Biopharma Services INC

    Toronto, M9L 3A2

Other trials in Canada

About this study

Official title: Multiple-dose, Randomized, Open-Label, Fasting, Two-period, Crossover, Bioavailability Study Between Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets in Healthy, Male Volunteers.

Comparative bioavailability of valproate from Orfiril long 500 mg prolonged-release mini-tablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting conditions.

Read the detailed description

Pivotal, multiple-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, crossover, study designed to evaluate the comparative bioavailability of valproate for Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablet once daily for 6 days in healthy male subjects under fasting conditions.

Being tested
Sodium valproate 500 MG, Valproic Acid 500 MG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium valproate 500 MGDrug

    Also called Orfiril long 500 mg

    oral intake

  • Valproic Acid 500 MGDrug

    Also called Ergenyl chrono 500 mg

    oral intake

Study groups in NCT06214130
Study groupRoleWhat they receive
TestExperimentalOrfiril long 500 mg (sodium valproate) prolonged-release minitablets
Receives: Drug: Sodium valproate 500 MG; Drug: Valproic Acid 500 MG
ReferenceActive comparatorErgenyl chrono 500 mg (valproic acid) prolonged -release tablets
Receives: Drug: Sodium valproate 500 MG; Drug: Valproic Acid 500 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve during steady state (AUCtau, ss)

    Comparative bioavailability under fasting steady state conditions, the 90% confidence intervals (CI) for the Test/Reference ratios of geometric means for AUCtau,ss should fall within 80.00%-125.00%.

    Measured: Day 6: pre-dose (0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18 and 24 hours post-dose.

  2. Maximal plasma concentration during steady state (Cmaxss)

    Comparative bioavailability under fasting steady state conditions, the 90% confidence intervals (CI) for the Test/Reference ratios of geometric means for AUCtau,ss should fall within 80.00%-125.00%.

    Measured: Day 6: pre-dose (0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18 and 24 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start22 Sep 2023
  3. Primary completion6 Nov 2023
  4. Study completion18 Nov 2023

Resources

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06214130
Sponsor's protocol ID
VPA-056/K
Status last verified
Jan 2024
First submitted
10 Jan 2024
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sodium valproate 500 MG and Valproic Acid 500 MG in people with Multiple Drug Use, 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 14 inclusion and 31 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 23 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 during steady state (AUCtau, ss) (time frame: Day 6: pre-dose (0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18 and 24 hours post-dose.). 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?

On the ClinicalTrials.gov record for NCT06214130.

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 23 Jan 2024.

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