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

Valenta Pharm JSC1 site in 1 country28 target enrollmentAugust 18, 2022

Overview

The study aimed for:

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.
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).

Registry

clinicaltrials.gov

Start Date

August 18, 2022

End Date

September 19, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Sponsor

Responsible Party

Sponsor

•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).
•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.

•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.
•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.

Group 1 (14 volunteers, RT sequence) will take 2 tablets of Diclectin in Period 1 and 2 tablets of Doxylamine + Pyridoxine in Period 2

Intervention: Doxylamine + Pyridoxine

Group 2 (14 volunteers, sequence TR) will take 2 tablets of Doxylamine + Pyridoxine in Period 1 and 2 tablets of Diclectin in Period 2.

Intervention: Doxylamine + Pyridoxine