Diphenhydramine citrate; Ibuprofen 布洛芬+苯海拉明.docVIP

精品资料 精品资料 PAGE / NUMPAGES 精品资料 Contains Nonbinding Recommendations Draft Guidance on Diphenhydramine Citrate and Ibuprofen This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Diphenhydramine citrate; Ibuprofen Tablet; oral Dosage Form; Route: Recommended Studies: Two studies 1. Type of study: Fasting Design: Single-dose, two-treatment, two-period crossover in vivo Strength: 38 mg; 200 mg Subjects: Males, non-lactating and non-pregnant females, general population Additional comments: None 2. Type of study: Fed Design: Single-dose, two-treatment, two-period crossover in vivo Strength: 38 mg; 200 mg Subjects: Males, non-lactating and non-pregnant females, general population Additional comments: None Analytes to measure (in appropriate biological fluid): Diphenhydramine and Ibuprofen in plasma Bioequivalence based on (90% CI): Diphenhydramine and Ibuprofen Waiver request of in vivo testing: Not applicable Dissolution test method and sampling times: The dissolution information for this drug product can be found on the FD A-Recommended Dissolution Methods web site, available to the public at the following location : . Conduct comparative dissolution testing on 12 dosage units each of all strengths of the test and reference products. Specifications will be determined upon review of the abbreviated new drug application. Recommended Feb 2010; Revised Sept 2019