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Guidelines for Biowaiver Regulations

Guidance for Submission Regulations

Data Requirements for the Renewal of Marketing Authorizations for human medicinal products Regulations

Policy Guidance for Pharmaceutical Reference Standard Regulations

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Amlodar Capsules (10 mg amlodipine) Produced by Dar AlDawa / Jordan versus Amlor® Capsules (10 mg amlodipine) Produced by Pfizer / KSA, in healthy subjects under fasting condition. Drug Clinical Trial

Randomized, three-way, three-period, single oral dose, open-label, crossover, bioequivalence study to compare Torvacol tablets (20 mg atorvastatin) Produced by JPM / Jordan, versus Lipitor® tablets (20 mg atorvastatin) Produced by Pfizer / Irland in healthy subjects under fasting conditions. Drug Clinical Trial

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Narapril tablets (20 mg enalapril) Produced by Julphar / UAE versus Renitec® tablets (20 mg enalapril) Produced by Merck Sharp & Dohme / UK, in healthy subjects under fasting condition. Drug Clinical Trial

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Glymide tablets (5 mg glibenclamide) Produced by Julphar / UAE versus Daonil® tablets (5 mg glibenclamide) Produced Sanofi-Aventis / Germany, in healthy subjects under fed condition. Drug Clinical Trial

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Amlophar Capsules (5 mg amlodipine) Produced by Julphar / UAE versus Amlor® Capsules (5 mg amlodipine) Produced by Pfizer / KSA, in healthy subjects under fasting condition. Drug Clinical Trial

Randomized, three-way, three-period, single oral dose, open-label, crossover, bioequivalence study to compare Lipomax tablets (20 mg atorvastatin) Produced by SAJA / KSA, versus Lipitor® tablets (20 mg atorvastatin) Produced by Pfizer / Ireland, in healthy subjects under fasting conditions. Drug Clinical Trial