Bioequivalence, AUC, Cmax, PharmacokineticsPhase 1NCT03121820
Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
A Phase 1 study testing Memantinol tablets, 20 mg and Akatinol Memantine® tablets, 20 mg in people with Bioequivalence, AUC, Cmax, Pharmacokinetics, run by Geropharm at 1 site in Russia.
Trial summary
This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, AUC, Cmax, Pharmacokinetics
- What is being tested?
- Memantinol tablets, 20 mg and Akatinol Memantine® tablets, 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteRussia
- Study dates
- 11 Oct 2016to 19 Nov 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form.
- Healthy male and female subjects aged 18 to 45 years.
- Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- Have a body mass index between 18,5 and 27 kg/m2.
- Females must have a negative pregnancy test.
- Subjects must use, with their partner, methods of highly effective contraception; if the Hormonal contraceptives was used they must canceled have at least 2 month before the study.
- from the time of IMP administration until 3 months after the last dose of IMP.
Who cannot join
- History of serious allergic problems/events
- Medicinal intolerance.
- History of allergic reactions to memantine or investigator's product components
- Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrinal systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Acute infectious diseases in less than 4 weeks before the start of the study.
- Subjects who have taken medication 4 weeks preceding before the study.
Show all 14Show fewer
- Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
- Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
- History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
- Smokers.
- Participation in other clinical training is less than than for 3 months before the study.
- Lack of signed informed consent form.
- ECG or vital signs abnormalities (clinically significant).
- Positive testing for alcohol, drugs, pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-way Crossover, Open-label, Single-dose, Fasting, Bioequivalence Study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg Tablets Versus Akatinol Memantine® (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg Tablets in Normal Healthy Subjects
This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects
Read the detailed description
Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg
- Being tested
- Memantinol tablets, 20 mg, Akatinol Memantine® tablets, 20 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memantinol tablets, 20 mgDrug
Also called memantine
Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition
Akatinol Memantine® tablets, 20 mgDrug
Also called memantine
Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition
| Study group | Role | What they receive |
|---|---|---|
| Memantinol tablets, 20 mg | Experimental | Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test) Receives: Drug: Memantinol tablets, 20 mg |
| Akatinol Memantine® tablets, 20 mg | Active comparator | Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \& Co. KGaA, Germany - reference) Receives: Drug: Akatinol Memantine® tablets, 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany)
Measured: 0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax)
Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany)
Measured: 0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start11 Oct 2016
- Primary completion19 Nov 2016
- Study completion19 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bioequivalence, AUC, Cmax, PharmacokineticsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two-way crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Igor Makarenko, MD, PhD, Study chair, Igor.Makarenko@geropharm.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121820
- Sponsor's protocol ID
- BIOMEM-20
- Status last verified
- Jul 2017
- First submitted
- 18 Apr 2017
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-way Crossover, Open-label, Single-dose, Fasting, Bioequivalence Study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg Tablets Versus Akatinol Memantine® (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg Tablets in Normal Healthy Subjects
- ClinicalTrials.gov ID
- NCT03121820
- Acronym / sponsor ID
- BIOMEM-20
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GeropharmIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 19 Nov 2016 (actual)
- Study completion
- 19 Nov 2016 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects
Detailed description
Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-way crossover
| Arm | Type | Receives |
|---|---|---|
| Memantinol tablets, 20 mg | Experimental | Drug: Memantinol tablets, 20 mgTreatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test) |
| Akatinol Memantine® tablets, 20 mg | Active comparator | Drug: Akatinol Memantine® tablets, 20 mgTreatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \& Co. KGaA, Germany - reference) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent form.
- Healthy male and female subjects aged 18 to 45 years.
- Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- Have a body mass index between 18,5 and 27 kg/m2.
- Females must have a negative pregnancy test.
Key exclusion criteria (14 listed)
- History of serious allergic problems/events
- Medicinal intolerance.
- History of allergic reactions to memantine or investigator's product components
- Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrinal systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Acute infectious diseases in less than 4 weeks before the start of the study.
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 |
|---|---|---|
| Memantinol tablets, 20 mgAlso: memantineBioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition | Drug | Memantinol tablets, 20 mg |
| Akatinol Memantine® tablets, 20 mgAlso: memantineBioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition | Drug | Akatinol Memantine® tablets, 20 mg |
Primary outcome
Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
Time frame: 0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany)
Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax)
Time frame: 0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Igor Makarenko, MD, PhD study chair
Igor.Makarenko@geropharm.com
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 Memantinol tablets, 20 mg and Akatinol Memantine® tablets, 20 mg in people with Bioequivalence, AUC, Cmax, Pharmacokinetics, run by Geropharm at 1 site in Russia.
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 7 inclusion and 14 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 29 Oct 2018. 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 Russia. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) (time frame: 0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 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?
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 29 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.