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Pregnancy RelatedNCT05498233

Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers

A study testing Doxylamine + Pyridoxine in people with Pregnancy Related and Nausea, run by Valenta Pharm JSC at 1 site in Russia.

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

The study aimed for: 1. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Doxylamine + Pyridoxine, enteric-soluble film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and Diclectin, delayed-release tablets, 10 mg + 10 mg (registrant: Tzamal Bio-Pharma, Israel… Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related, Nausea
What is being tested?
Doxylamine + Pyridoxine
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 siteRussia
Study dates
18 Aug 2022to 19 Sep 2022
Phase
Interventional
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 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study before any of the study procedures.
  • Women of reproductive age (18 to 49 years inclusive, according to World Health Organization criteria).
  • Verified diagnosis "healthy" (absence of abnormalities according to clinical, laboratory, instrumental methods of examination stipulated by the protocol).
  • Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 139 mmHg, diastolic blood pressure (DBP) from 60 to 89 mmHg (inclusive).
  • Heart rate (HR) from 60 to 90 bpm (inclusive).
  • Respiratory rate (HR) from 12 to 18 bpm (inclusive).
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  • Body temperature of 36 to 36.9°C (inclusive).
  • Body mass index (BMI) is 18.5 ≤ BMI ≤ 30 kg/m2, and the body weight must be ≥ 45 kg.
  • Consent to use adequate methods of contraception throughout the study and for 30 days after completion, negative pregnancy test.
  • Volunteers must behave adequately, coherent speech must be observed.

Who cannot join

  • A history of allergic reactions.
  • Drug intolerance of active and/or excipients included in the study drugs in the anamnesis.
  • Chronic diseases of the cardiovascular, lymphatic, respiratory, nervous, endocrine, digestive, musculoskeletal, covering, immune systems, as well as of the urogenital system and hematopoietic organs.
  • Values of standard laboratory and instrumental indices beyond the limits of local laboratory norms.
  • History of gastrointestinal surgery (except appendectomy at least 1 year before screening).
  • Diseases/conditions that the investigator believes may affect the absorption, distribution, metabolism, or excretion of the study medication.
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  • Acute infectious disease less than 4 weeks prior to screening.
  • Taking drugs that have a significant effect on hemodynamics and drugs that affect liver function (barbiturates, benzodiazepines, omeprazole, cimetidine, etc.) for less than one month before screening.
  • Regular intake of drugs less than 2 weeks before screening and one-time intake of drugs less than 7 days before screening.
  • Donating blood or plasma less than 3 months before the screening visit.
  • Use of hormonal contraceptives less than 2 months before the screening visit.
  • Using depot injections of any medications less than 3 months prior to the screening visit.
  • Pregnancy or lactation, positive pregnancy test.
  • Participation in another clinical trial less than 3 months before screening or concurrently with this study.
  • Taking more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 ml of beer, 150 ml of wine, or 40 ml of spirits) in the week in the last month before inclusion in the study or anamnestic evidence of alcoholism, drug abuse, or medicine abuse.
  • Smoking.
  • Positive blood tests for antibodies to human immunodeficiency virus (HIV) type 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens, laboratory examination of biomaterial (nasopharyngeal swab) for SARS-Cov-2 RNA (COVID-19).
  • Clinically significant abnormalities on electrocardiogram (ECG).
  • Positive urinalysis for narcotics and powerful drugs.
  • Positive breath alcohol vapor test.
  • Scheduling an inpatient stay during the study period, for any reason other than hospitalization required by this protocol.
  • Failure or inability to comply with protocol requirements, perform protocol-prescribed procedures, diet, and activity regimen.
  • Observance of a religious fast or special diet (e.g., vegetarian, vegan).
  • Other conditions that, in the opinion of the Investigator, preclude a volunteer from enrolling in the study or may result in early withdrawal from the study, including special lifestyles (night work, extreme physical activity).
  • Withdrawal criteria:
  • The volunteer's refusal to further participate in the study.
  • Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.).
  • Occurrence of causes/occurrence during the study of situations that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.).
  • Volunteers included in the study in violation of the inclusion/inclusion criteria.
  • Development of a severe and/or serious adverse event (AE) in a volunteer during the study.
  • Missing 2 or more consecutive blood samples or 3 or more blood samples during one Period of the pharmacokinetic portion of the study.
  • Occurrence of vomiting/diarrhea within 24 h of study drug administration (the choice of time interval is based on the tmax parameter value for doxylamine and pyridoxal-5-phosphate not exceeding 7.2 ± 1.9 and 11.7 ± 5.3 h, respectively, according to the manufacturer of the reference drug).
  • Positive urine test for narcotic substances and potent drugs.
  • Positive breath alcohol vapor test.
  • A positive pregnancy test.
  • Positive test for SARS-Cov-2 RNA (COVID-19);
  • Other causes occurring in the course of the study that prevent the study from being conducted according to the protocol.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Llc "Certa Clinic"

    Moscow

Other trials in Russia

About this study

Official title: Open Randomized Cross-over Two-period Study on Comparative Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Enteric-soluble Film-coated Tablets, 10 mg + 10 mg (Valenta Farm, Russia) in Healthy Volunteers in Fasted Conditions

The study aimed for:

  1. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Doxylamine + Pyridoxine, enteric-soluble film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and Diclectin, delayed-release tablets, 10 mg + 10 mg (registrant: Tzamal Bio-Pharma, Israel, manufacturer: Duchesnay Inc, Canada), in healthy volunteers in fasted conditions.
  2. Comparative evaluation of the safety of the drug Doxylamine + Pyridoxine, enteric-soluble film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSK, Russia), and Diclectin, delayed-release tablets, 10 mg + 10 mg (registrant: Tzamal Bio-Pharma, Israel, manufacturer: Duchesnay Inc, Canada), based on the analysis of adverse events (AEs).
Being tested
Doxylamine + Pyridoxine
Medical subject headings
Nausea

What participants receive

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

  • Doxylamine + PyridoxineDrug

    A single dose of R or T drug in each of 2 periods of the study in fasted conditions

Study groups in NCT05498233
Study groupRoleWhat they receive
RT-sequenceOtherGroup 1 (14 volunteers, RT sequence) will take 2 tablets of Diclectin in Period 1 and 2 tablets of Doxylamine + Pyridoxine in Period 2
Receives: Drug: Doxylamine + Pyridoxine
TR-sequenceOtherGroup 2 (14 volunteers, sequence TR) will take 2 tablets of Doxylamine + Pyridoxine in Period 1 and 2 tablets of Diclectin in Period 2.
Receives: Drug: Doxylamine + Pyridoxine

What is being measured

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

  1. Pharmacokinetics - Cmax (Doxylamine)

    Maximum plasma concentration (Cmax)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  2. Pharmacokinetics - Cmax (Pyridoxal-5-phosphate)

    Maximum plasma concentration (Cmax)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  3. Pharmacokinetics - tmax (Doxylamine)

    Time to reach Cmax (tmax)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  4. Pharmacokinetics - tmax (Pyridoxal-5-phosphate)

    Time to reach Cmax (tmax)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  5. Pharmacokinetics - AUC0-t (Doxylamine)

    Area under the plasma concentration-time curve from time 0 to t (AUC0-t)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  6. Pharmacokinetics - AUC0-t (Pyridoxal-5-phosphate)

    Area under the plasma concentration-time curve from time 0 to t (AUC0-t)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  7. Pharmacokinetics - AUC0-inf (Doxylamine)

    Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  8. Pharmacokinetics - AUC0-inf (Pyridoxal-5-phosphate)

    Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  9. Pharmacokinetics - AUCextr (Doxylamine)

    Extrapolated AUC, defined as (AUC0-inf - AUC0-t)/AUC0-inf

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  10. Pharmacokinetics - AUCextr (Pyridoxal-5-phosphate)

    Extrapolated AUC, defined as (AUC0-inf - AUC0-t)/AUC0-inf

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  11. Pharmacokinetics - t1/2 (Doxylamine)

    Elimination half-life (t1/2)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  12. Pharmacokinetics - t1/2 (Pyridoxal-5-phosphate)

    Elimination half-life (t1/2)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  13. Pharmacokinetics - kel (Doxylamine)

    Elimination constant (kel)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  14. Pharmacokinetics - kel (Pyridoxal-5-phosphate)

    Elimination constant (kel)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  15. Pharmacokinetics - MRT (Doxylamine)

    Mean residence time (MRT)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  16. Pharmacokinetics - MRT (Pyridoxal-5-phosphate)

    Mean residence time (MRT)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  17. Bioequivalence - ratio of Cmax (Doxylamine)

    Ratio of geometric mean Cmax after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  18. Bioequivalence - ratio of Cmax (Pyridoxal-5-phosphate)

    Ratio of geometric mean Cmax after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  19. Bioequivalence - ratio of AUC0-t (Doxylamine)

    Ratio of geometric mean AUC0-t after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  20. Bioequivalence - ratio of AUC0-t (Pyridoxal-5-phosphate)

    Ratio of geometric mean AUC0-t after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  21. Bioequivalence - ratio of AUC0-inf (Doxylamine)

    Ratio of geometric mean AUC0-inf after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

  22. Bioequivalence - ratio of AUC0-inf (Pyridoxal-5-phosphate)

    Ratio of geometric mean AUC0-inf after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 72 hours (Day 1-4 and Day 22-25)

Secondary outcomes (43)

  1. Safety and Tolerability: adverse event (AE) number and frequency

    Number and frequency of adverse events (AEs)

    Measured: From the screening (and signing informed consent form) to Day 29 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 29)

  2. serious adverse event (SAE) number and frequency

    Number and frequency of serious AEs (SAEs)

    Measured: From the screening (and signing informed consent form) to Day 29 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 29)

  3. Safety and Tolerability: vital signs - systolic blood pressure (SBP)

    SBP, mmHg

    Measured: Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  4. Safety and Tolerability: vital signs - diastolic blood pressure (DBP)

    DBP, mmHg

    Measured: Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  5. Safety and Tolerability: vital signs - respiratory rate (RR)

    RR, breaths per minute

    Measured: Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  6. Safety and Tolerability: vital signs - heart rate (HR)

    HR, beats per minute

    Measured: Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  7. Safety and Tolerability: vital signs - body temperature

    Body temperature, centigrade scale

    Measured: Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  8. Safety and Tolerability: physical examination results

    Physical examination will follow the general rules of internal medicine: general examination, examination of mucous membranes and skin, including palpation of lymph nodes, evaluation of the musculoskeletal system, palpation, percussion, and auscultation of the main organ systems (cardiovascular, respiratory, digestive, and urinary systems) will be performed sequentially.

    Measured: Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  9. Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  10. Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  11. Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  12. Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  13. Safety and Tolerability: urinalysis - color

    Color of the urine

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  14. Safety and Tolerability: urinalysis - transparency

    Transparency of the urine

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  15. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  16. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  17. Safety and Tolerability: urinalysis - protein

    Protein in the urine (g/L)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  18. Safety and Tolerability: urinalysis - glucose

    Glucose in the urine (mmol/L)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  19. Safety and Tolerability: urinalysis (microscopy) - red blood cells

    Red blood cells in the urine (number in sight)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  20. Safety and Tolerability: urinalysis (microscopy) - white blood cells

    White blood cells in the urine (number in sight)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  21. Safety and Tolerability: urinalysis (microscopy) - epithelial cells

    Epithelial cells in the urine (number in sight)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  22. Safety and Tolerability: urinalysis (microscopy) - cylinders

    Cylinders in the urine (number in sight)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  23. Safety and Tolerability: urinalysis (microscopy) - mucus

    Mucus in the urine (presence in sight)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  24. Safety and Tolerability: urinalysis (microscopy) - bacteria

    Bacteria in the urine (number in sight)

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  25. Safety and Tolerability: complete blood count - hemoglobin

    Hemoglobin, g/dL

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  26. Safety and Tolerability: complete blood count - red blood cells

    Red blood cells, 10^6/uL

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  27. Safety and Tolerability: complete blood count - hematocrit

    Hematocrit, %

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  28. Safety and Tolerability: complete blood count - platelets

    Platelets, 10^3/uL

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  29. Safety and Tolerability: complete blood count - white blood cells

    White blood cells, 10^3/uL

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  30. Safety and Tolerability: complete blood count - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate, mm per hour

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  31. Safety and Tolerability: complete blood count - neutrophils

    Neutrophils, %

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  32. Safety and Tolerability: complete blood count - lymphocytes

    Lymphocytes, %

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  33. Safety and Tolerability: complete blood count - eosinophils

    Eosinophils, %

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  34. Safety and Tolerability: complete blood count - monocytes

    Monocytes, %

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  35. Safety and Tolerability: complete blood count - basophils

    Basophils, %

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  36. Safety and Tolerability: blood test results - total protein

    Total protein in blood serum, g/L

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  37. Safety and Tolerability: blood test results - creatinine

    Creatinine in blood serum, umol/L

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  38. Safety and Tolerability: blood test results - glucose

    Glucose in blood serum, mmol/L

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  39. Safety and Tolerability: blood test results - total bilirubin

    Total bilirubin in blood serum, umol/L

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  40. Safety and Tolerability: blood test results - total cholesterol

    Total cholesterol in blood serum, mmol/L

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  41. Safety and Tolerability: blood test results - alanine transaminase (ALT)

    ALT in blood serum, U/L

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  42. Safety and Tolerability: blood test results - aspartate transaminase (AST)

    AST in blood serum, U/L

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

  43. Safety and Tolerability: blood test results - alkaline phosphatase (ALP)

    ALP in blood serum, U/L

    Measured: Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29)

Timeline

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

  1. First posted12 Aug 2022
  2. Study start18 Aug 2022
  3. Primary completion19 Sep 2022
  4. Study completion19 Sep 2022

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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05498233
Sponsor's protocol ID
DIP-05-01-2022
Status last verified
Jul 2023
First submitted
9 Aug 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Doxylamine + Pyridoxine in people with Pregnancy Related and Nausea, run by Valenta Pharm JSC 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 10 inclusion and 37 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 27 Jul 2023. 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.

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?

Pharmacokinetics - Cmax (Doxylamine) (time frame: From 0 to 72 hours (Day 1-4 and Day 22-25)). The study lists 22 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 NCT05498233.

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 27 Jul 2023.

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