Bioequivalence study of Doxylamine Succinate 20 mg Pyridoxine HCl 20 mg Extended-Release tablets in healthy adult female subjects under fasting conditio
- Registration Number
- CTRI/2023/05/052878
- Lead Sponsor
- Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
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-â??Timepoint: From Day 01 to Day 34 <br/ ><br>
- Secondary Outcome Measures
Name Time Method To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From Day 01 to Day 34