None listed
Conditions
Interventions
Intervention1: Dynapar QPS Plus 2.32% w/v of Troikaa Pharmaceuticals Ltd: Dynapar QPS Plus 2.32% w/v (Diclofenac diethylamine BP: 2.32% w/v equivalent to Diclofenac sodium IP
(1ml of solution equivale
Sponsors
Troikaa Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subjects aged between 18 and 45 years (both inclusive) of both gender. 2 Subjects weight within normal range according to normal values for Body Mass Index (between 18.50 and 30.00 kg/m2) (both inclusive) with greater than equal to 50 kg weight. 3 Subject with hemoglobin level greater than equal to 11.5 gm percent at the time of screening. 4 Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable range. 5 Subjects having clinically acceptable 12-lead electrocardiogram (ECG). 6 Subjects having clinically acceptable chest X-Ray (PA view), if taken. 7 Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine). 8 Subjects having negative Urine alcohol /alcohol breath test. 9 Subjects who are Non-smokers. 10 Subjects willing to adhere to the protocol requirements and to provide written informed consent. 11 For male Subjects: Subjects willing to follow approved birth control methods for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects should also not donate sperm during study period. 12 Subjects having negative urine pregnancy test at screening and negative serum Beta-hCG Pregnancy test on admission day of period 01. (For female subject). 13 For Female Subjects: Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom plus diaphragm, condom plus spermicidal or foam. Or Postmenopausal for at least 1 year, or if less than 1 year, then acceptable contraceptive measures as mentioned above. Or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Exclusion criteria
Exclusion criteria: 1 Hypersensitivity to Diclofenac or related class of drugs or any of its excipients or heparin. 2 History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder. 3 Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission of period-01. 4 Presence of alcoholism or drug abuse. 5 History or presence of asthma, urticaria or other significant allergic reactions. 6 History or presence of significant gastric and/or duodenal ulceration. 7 History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor. 8 History or presence of cancer or basal or squamous cell carcinoma. 9 Difficulty with donating blood. 10 Use of any prescribed medication or OTC medication including vaccine, vitamins and herbal remedies during last 30 days prior to admission of period 01. 11 Major illness within past 3 months. 12 Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug. 13 Consumption of xanthine-containing products, tobacco containing products, alcohol or alcoholic products for within 48.00 hours prior to admission of period 01. 14 Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01. 15 Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C. 16 History or presence of significant easy bruising or bleeding. 17 History or presence of significant recent trauma. 18 Any contraindication to cannulation or blood sampling. 19 Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study. 20 Female subjects who are currently pregnant or breast feeding. 21 Subjects who have Bruises, damaged skin, eczema or wounds on the application site, or the application site inappropriate for applying the IMP as per PI discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters: Cmax, AUC(0-t), AUC(0-8), Tmax, AUC_% Extrap_obs, t1/2 & Kel.Timepoint: A total of 19 blood samples will be collected during each study period. The pre-dose blood sample of 4.0 mL (0.00 hour) will be collected within one hour prior to scheduled time of dosing in each study period. The post-dose blood samples of 4.0 mL each will be drawn at 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 16.00, 18.00, 20.00, 22.00 & 24.00 hours after dosing in each study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety & tolerability of subjectsTimepoint: Vital signs (blood pressure & radial pulse rate) will be measured before dosing of investigational products (within one hour prior to dosing) & at 1.00, 3.00, 6.00, and 13.00 hours after dosing in each period. Post-dose blood pressure and radial pulse rate will be measured within ± 45 minutes of the scheduled time in sitting posture. | — |
Countries
India
Contacts
Public ContactMr Vivek Kumar Agarwal
Troikaa Pharmaceuticals Ltd.
Outcome results
None listed