None listed
Conditions
Interventions
Intervention1: YOMESAN® tablets: YOMESAN® tablets (niclosamide) 500 mg of Bayer (Pty) Ltd, 27 Wrench Road, Isando, 1609
Frequency: Day1 : Single dose (4 x 500 mg)
Day 2 to Day 7: Single (2 x 500 mg)
Sponsors
Daewoong Pharmaceutical India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Normal healthy adult male and/or female volunteers between 18-45 years (both ages inclusive) of age. 2. Who provided written informed consent and are willing to participate in the study. 3. Volunteer having bodyweight minimum of 50 kg. 4. Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive). 5. No evidence of underlying disease during the pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study. 6. Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study. 7. Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR. 8. Volunteer who are non-smoker, non-tobacco (in any form) users; non-alcoholic with negative test for alcohol, Negative urine drug of abuse test (Tetrahydrocannabinol (THC), Opiates, Cocaine, Barbiturates, Amphetamine and Benzodiazepines). 9. 12 lead ECG recording either normal or within acceptable limits or as considered by the Investigator to be of no clinical significance with respect to his/her participation in the study. 10. Chest X-ray taken within 06 months before the day of dosing, which is considered as normal or clinically insignificant as per Investigator discretion. 11. Available for the entire study period and capable of understanding instructions and communicating with the investigators and clinical study facility staff. 12. Female volunteers who is having negative results in urine pregnancy test during screening and Beta hCG-test at the time of check-in. 13. Female volunteers of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment (Preferably two methods). 14. Male volunteers and/or Female volunteers partner must agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 30 days after dosing of study treatment (Preferably two methods).
Exclusion criteria
Exclusion criteria: 1. Known allergy to Niclosamide or any component of the formulation and to any other related drug. 2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 3. Female volunteers who are nursing motherslactating women or are found positive in beta hCG test. 4. History/ current use of Alcohol or drug abuse. 5. History/ current smoker or tobacco (in any form) user. 6. History/presence of asthma 7. History/presence of urticaria or other allergic type reactions after taking any medication. 8. History/presence of clinically significant illness within 04 weeks before the start of the study. 9. History of clinically relevant allergy (except for untreated, seasonal allergies at time of dosing) or any allergic reactions to any drugs. 10. Who is scheduled for surgery any time during study or within 30 days after dosing of study treatment. 11. History of difficulty in donating blood. 12. Who has unsuitable veins for repeated venipuncture. 13. Who is participating in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days. 14. Who has taken prescription medication or over-the-counter products (including vitamins and products from natural origin e.g. St. Johnâ??s Wort) within 14 days prior to administration of study medication, including topical medication meant for systemic absorption. 15. Who was hospitalized within 28 days prior to administration of the study medication. 16. History of difficulty in swallowing. 17. Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial. 18. Who has Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator. 19. Who has Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoint Single-dose PK assessment: on Day 01 & Day 02 Cmax, AUCinf and AUC0-t Multiple-dose (Steady state) PK assessment: On Day 07 AUC (0-Ï?)ss, Cmax,ss, and CÏ?,ss. Timepoint: Day 01:Pre-dose 00.00 and post-dose at 00.25,00.33,00.50,00.75,1.00,1.50,2.00,2.50,3.00,4.00, 6.00,8.00,10.00,12.00 and15.00 hrs Day 02:Pre-dose sample 00.00 and post-dose at 00.25,00.33,00.50,00.75,1.00,1.50,2.00,2.50,3.00, 4.00,6.00,8.00,10.00,12.00 and15.00 hrs Day 07:Pre-dose 00.00 and post-dose at 00.25,00.33,00.50,00.75,1.00,1.50,2.00,2.50,3.00,4.00,6.00,8.00,10.00,12.00 and15.00 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Single-dose PK assessment: on Day 01 & Day 02 Secondary Outcomes: tmax, t1/2 and MRT Multiple-dose (Steady state) PK assessment: On Day 07 Secondary Outcomes: Cavg,ss, tmax,ss, AUCinf, t1/2,ss, CLss/F and Vdss/F. Timepoint: Day 01:Pre-dose 00.00 and post-dose at 00.25,00.33,00.50,00.75,1.00,1.50,2.00,2.50,3.00,4.00, 6.00,8.00,10.00,12.00 and15.00 hrs Day 02:Pre-dose sample 00.00 and post-dose at 00.25,00.33,00.50,00.75,1.00,1.50,2.00,2.50,3.00, 4.00,6.00,8.00,10.00,12.00 and15.00 hrs Day 07:Pre-dose 00.00 and post-dose at 00.25,00.33,00.50,00.75,1.00,1.50,2.00,2.50,3.00,4.00,6.00,8.00,10.00,12.00 and15.00 hrs | — |
Countries
India
Contacts
Public ContactMr Lakshmikanth Maddela
Ecron Acunova Limited
Outcome results
None listed