A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)

Summary

This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-1006 will be similar.

Timeline

Start

2009-09

Primary completion

2009-11

Completion

2009-12

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); MK-1006 80 mg FCT vs MK-1006 80 mg DFC; Geometric mean ratio 0.93 (90% CI 0.86 to 0.99) NCT00979459 ↗

registry analysis (non-inferiority or equivalence test); MK-1006 80 mg FCT vs MK-1006 80 mg DFC; Geometric mean ratio 1.07 (90% CI 0.92 to 1.24) NCT00979459 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MK-1006	Unknown	80 mg	—

Indications