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Report for Clinical Trial NCT00930215

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects

The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5

NCT00930215 Healthy

2 Interventions

Name: D961H

Description: Oral gelatin capsule

Type: Drug

D961H 40 mg gelatin capsule

Name: D961H

Description: Oral HPMC capsule

Type: Drug

D961H 40 mg HPMC capsule


Primary Outcomes

Measure: Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5

Time: PK sample at Day 5 of treatment period 1 and treatment period 2

Secondary Outcomes

Measure: Evaluate the PK properties of HPMC capsule of D961H 40 mg following repeated oral doses, by assessment of plasma concentrations, mean residence time, time to maximum plasma concentration and half-life on Day 5

Time: PK sample on Day 5 of treatment period 1 and treatment period 2

Measure: Evaluate the safety and tolerability of HPMC capsule of D961H 40 mg by assessment of AEs, clinical lab tests, ECG, vital signs.

Time: Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose)

Allocation: Randomized

Single Group Assignment


There is one SNP

SNPs


1 D961H

Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961H ---

Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961H --- --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H --- --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H --- --- D961H --- --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Evaluate the PK properties of HPMC capsule of D961H 40 mg following repeated oral doses, by assessment of plasma concentrations, mean residence time, time to maximum plasma concentration and half-life on Day 5. null. --- D961H ---

Evaluate the safety and tolerability of HPMC capsule of D961H 40 mg by assessment of AEs, clinical lab tests, ECG, vital signs.. null. --- D961H ---



HPO Nodes