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Vilazodone Hydrochloride 1.20 General Investigational Plan

TWIND Pharmaceuticals PVT.LTD 12/16/20

1.20 GENERAL INVESTIGATIONAL PLAN 1.20.1 Rationale: Major Depressive Disorder (MDD) affects “121 million people globally” 1and is one of the leading causes of functional disability worldwide. MDD is a recurring disorder and thus is associated with significant illness as well as high direct and indirect costs to the health care system. Cases where the patient has achieved sustained reduction from MDD, are very rare, despite the various therapies in the market. Vilazodone’s distinctive pharmacological profile makes it more effective than other drugs which are currently available. This trial is for research of the investigational new drug Vilazodone hydrochloride, which can potentially be used in the treatment of MDD. This trial will determine the safety of the drug in humans, so that further studies can be carried out on its effectiveness. 1.20.2 Indication(s) to be Studied: Major Depressive Disorder is the indication for which the study is being carried out . The study the food influence on the BA profile of Vilazodone Hydrochloride which includes changes in various factors such as change of pH in GI, physical and chemical interactions with excipient and active pharmaceutical ingredients (APIs), diet with high calories2 and fats. The main purpose of this trial is to evaluate the impact of food on drug absorption 1.20.3 General Approach for Evaluation of Treatment: 1.20.3.1Safety Evaluations 

Change in respiratory rate, sitting radial pulses and sitting systolic and diastolic pressures will be collected after intervals of 30 mins on the day the dose is administered3. 1.20.3.2 Other Evaluations

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Pharmacokinetic assessments are made by collecting blood samples which are drawn at 5 min pre-dose, and 0.25, 1, 3, 6, 12 and 24 hours post-dose.

1.20.4 Description of First Year Trial(s): The Vilazodone Hydrochloride phase 1 trial is the first-year trial, includes the research that takes place of about 4 weeks on the healthy volunteers. This is a single center, open-label, randomized sequence, 2-period crossover, multiple-dose (2 single doses with a 7-day washout period between doses) phase Ⅰ trial. 1.20.5 Number of Subjects to be Evaluated: There are up to 20 Healthy patients which are given with Vilazodone Hydrochloride or Placebo Randomly in 1:1 ratio. Using a software developed by the study data management provider which is known as SAS- based computer generated randomization scheme

Vilazodone Hydrochloride 1.20 General Investigational Plan

TWIND Pharmaceuticals PVT.LTD 12/16/20

1.20.6 Drug Related Risks: The anticipated risks recognized using this drug on animals, and that may show high risk on humans as well, which may involve feeling of anxiety, restlessness, seizures, and suicidal tendencies on initial phase of use.

1.20.7 REFERENCES : 1.Iranikhah M, W. T. (2012, October). Vilazodone for the treatment of major depressive disorder. Retrieved from Pubmed: https://www.ncbi.nlm.nih.gov/pubmed/23033234

2.Centre for drug evaluation and research application number022567orig1s000 clinical pharmacology and biopharmaceutics review(S) Accessdata.Fda.Gov. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567orig1s000pharmr.pdf. accessed October 28, 2016. 3.Clayton Ah, Mcgarvey El, Clavet Gj, Piazza L. (1997). Comparison of Sexual Functioning In Clinical And Nonclinical Populations Using The Changes In Sexual Functioning Questionnaire (Csfq). Psycho pharmacology Bull 33:747–753. [PubMed]...