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

Recruiting

• Conditions: Fasting condition

• Registration Number: CTRI/2023/05/052878
• Lead Sponsor: Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited)

Brief Summary

**STUDY TITLE:**

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.

**OBJECTIVES:**

**Primary objective:**

To compare the rate and extent of absorption of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release) tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) with that of 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.

**Secondary objective:**

To monitor the safety and tolerability of the study subjects after administration of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release)} tablets in healthy, adult, female subjects under fasting condition.



**Number of subjects:** Thirty two (32)



**Duration of clinical study:** 34 Days

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-26
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 32

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

• 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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞	From Day 01 to Day 34

Secondary Outcome Measures

Name	Time	Method
To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2	From Day 01 to Day 34

Trial Locations

Locations (1)

ICBio Clinical Research Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

ICBio Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Priya R

Principal investigator

9900111997

pi.mail@icbiocro.com