A clinical trial to study the effects of two drugs, Methotrexate tablets USP 15 mg / Trexall® in Patients with suffering from psoriasis.

Not Applicable

• Conditions: Health Condition 1: null- Adult patients suffering from psoriasis

• Registration Number: CTRI/2015/01/005427
• Lead Sponsor: Zhejiang Hisun Pharma Co Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

1.Adult patients suffering from psoriasis; aged between 18 to 45 years (both inclusive)

2.Patients should already be receiving 15 mg once weekly for psoriasis

3.Patients willing to voluntarily provide written informed consent.

4.Patients willing to undergo pre and post-study physical examinations and laboratory investigations.

5.Patients willing to adhere to protocol and they should not consume coffee, tea, chocolate, grape fruit juice or soft drink at least 24 hours prior to investigational product administration (i.e. in house monitoring and the remaining based on history) and during their clinical stay in each study period.

6.Patient should be willing to adhere to the protocol and they should not consume alcohol at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and should agree not to take any amount of alcohol during the study period.

Exclusion Criteria

1.Patients incapable of understanding the informed consent process.

2.Pregnant [female patients with a positive pregnancy test at screening or positive serum β-HCG test (done at Check-in of each study period)] or lactating females

3.Female patients of childbearing potential who is unwilling or unable to use an appropriate method of contraception, at least 14 days prior to the first dose of study medication until the poststudy follow-up (i.e. 7 days after the last dosing in Period II). Female patients using hormonal contraceptives either oral or implants.

4.Female patients with history of dysmenorrhea requiring medication

5.Patients with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study

6.Patients with evidence of psychiatric disorder likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements.

7.Patients with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results.

8.Any treatment which could affect the pharmacokinetic of methotrexate (salicylates, hypoglycaemics, diuretics, sulphonamides, diphenylhydantoins, tetracyclines, chloramphenicol and p-aminobenzoic acid, the acidic anti-inflammatory agents, probenecid, penicillins, Chloroquine, omeprazole, etretinate, co-trimoxazole and trimethoprim etc.) administered within 1 month of starting of study/in past 1 month.

9.Patients with history of drug hyper sensitivity to methotrexate or related drugs or to any of the excipient of the formulation

10.Patients with a history of alcohol, found with current alcohol abuse based on Alcohol breath test and with history of drug abuse, found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates).

11.Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus reactive/positive.

12.Patients with clinically significant abnormal haemoglobin (Hb), total white blood cells count (WBC), differential WBC count, platelet count and hematocrit

13.Patients who, have clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen, (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase

(ALT), serum alkaline phosphatase (ALP), c-glutamyltranspeptidase, serum bilirubin, serum glucose (fasting) etc.

14.Patients with clinically significant abnormal urine analysis, defined as the presence of RBC (5/HPF), pus cells (5/HPF), epithelial cells (5/HPF), glucose (positive), ketones (positive), bilirubin (positive) and protein (positive)

15.Patients with clinically significant abnormal results during ultrasonographic examinations.

16.Patients with a clinically significant past history or current medical condition of:

• Pulmonary disorders (COPD and asthma)

• Cardiovascular disorders (especially cardiac blocks)

• Neurological disorders (especially seizures, migraine)

• GIT disorders including history or presence of significant gastric and/or duodenal ulceration

• Renal and/or hepatic disorders

• Coagulation disorders

• Endocrine disorders (especially diabetes mellitus)

• History or pre

Study & Design

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

Primary Outcome Measures

Name	Time	Method
To establish the bioequivalence of test Methotrexate tablets USP 15 mg (from Zhejiang Hisun Pharma Co. Ltd., China) with reference Trexall® (methotrexate tablets USP) 15 mg of Barr Pharmaceuticals, Inc., USA. <br/ ><br>Bioequivalence of the two formulations (T vs R) in relation to the: <br/ ><br>oCmax, <br/ ><br>oAUC0â??t <br/ ><br>oAUC0-â?? <br/ ><br>Timepoint: NA

Secondary Outcome Measures

Name	Time	Method
To monitor all the adverse events, including laboratory parameters <br/ ><br>2. To determine other pharmacokinetic parameters of test and reference products <br/ ><br>oTmax, <br/ ><br>oKel <br/ ><br>ot1/2 <br/ ><br>oTlag - lag time <br/ ><br>oAUC_%Extrap_obs <br/ ><br>oλz <br/ ><br>Timepoint: NA