IRCT20130313012810N31CompletedUnknown
Comparative bioequivalence study of the Tizanidine Hydrochloride 4 mg tablet manufactured by Amin Pharmaceutical Company
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Amin Pharmaceutical Co
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 50 years (—)
- Sex
- All
Inclusion Criteria
- •The weight range of participating candidates should be between 60-100 kg.
- •Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose.
- •Volunteers who have agreed to an informed consent form.
- •All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw.
Exclusion Criteria
- •History of allergic or adverse reaction to Tizanidine HCl or any similar product.
- •Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
- •Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s).
Investigators
Similar Trials
Completed
Phase 1
Bioequivalence Study of Trimetazidine Dihydrochloride 35 mg Modified Release Tablets in Healthy VolunteersTCTR20190703003Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University69
Completed
Phase 1
A Bioequivalence Study of Two Formulations of Ticagrelor 90-mg Tablets in Healthy Thai Subjects under Fasting ConditionsHealthy VolunteersBioequivalenceTicagrelorPharmacokineticsTCTR20230206006Sun Pharmaceutical Industries Ltd.31
Completed
Phase 1
Bioequivalence study of Trimetazidine Dihydrochloride 80 mg PR capsules in heathy Thai volunteer under fed conditioBioequivalence study of Trimetazidine Dihydrochloride 80 mg PR capsules in heathy Thai volunteer under fed conditionTCTR20230320011nison Laboratories Co., Ltd.30
Completed
Phase 1
Bioequivalence study of Trimetazidine Dihydrochloride 80 mg PR capsules in heathy Thai volunteer under fasting conditioBioequivalence study of Trimetazidine Dihydrochloride 80 mg PR capsules in heathy Thai volunteer under fasting conditionTCTR20230706005nison Laboratories Co., Ltd.30
Recruiting
Not Applicable
Bioequivalence study of Tinidazole 500 mg tabletIn the present study, the products will be administered to healthy volunteers..IRCT20210519051345N17Tabriz University of Medical Sciences24