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Bioequivalence study of Doxylamine Succinate 20 mg Pyridoxine HCl 20 mg Extended-Release tablets in healthy adult female subjects under fasting condition

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release) tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) in comparison with Bonjesta 20/20 tablets {Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release)} of Duchesnay USA, Inc. in healthy, adult, female subjects under fasting condition.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052878
Enrollment
32
Registered
2023-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release) tablets: Name of the drug:Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg Route of administration: Oral Frequency:

Sponsors

Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Study subjects should avoid consuming foods/beverages with high vitamin B6 contents from the time of entry to end of treatment visit 2. Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 3. Willing to be available for the entire study period and to comply with protocol requirements 4. Normal healthy adult female subject of 18 45 years of age 5. Body mass index in the range of 18 30 kg m2

Exclusion criteria

Exclusion criteria: 1. Any medical or surgical condition which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs 2. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past 3. History of severe infection or major surgery in the past 6 months 4. History of Minor surgery or fracture within the past 3 months 5. Significant history or current evidence of malignancy or chronic infectious cardiovascular renal hepatic ophthalmic pulmonary neurological metabolic endocrine hematological gastrointestinal immunological or psychiatric diseases or organ dysfunction

Design outcomes

Primary

MeasureTime frame
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-â??Timepoint: From Day 01 to Day 34—

Secondary

MeasureTime frame
To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From Day 01 to Day 34—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026