Bioequivalence and Food Effect Study in Healthy Volunteers

• Status: Completed
• Trial end date: 2007-09-26
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion criteria:

• Healthy adult male subjects aged between 18 and 65 years of age inclusive.

• Body weight and BMI within the protocol ranges.

• Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.

• Circulating levels of LH, FSH and testosterone within the normal reference range.

• Signed and dated written informed consent.

• The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion criteria:

• Positive pre-study urine drug screen and alcohol breath test.

• Positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV ½ result.

• Abuse of alcohol as per protocol criteria.

• Consumption of prohibited food and drink as per protocol.

• Subject who is not prepared to eat the standard meals provided by the site.

• Use of prescription or non-prescription drugs 1 or 2 weeks before the first dose of study medication.

• Where participation in study would result in donation of blood in excess of 500mL within a 56 day period.

• History or presence of allergy to the study drug or drugs of this class, or a history of other allergy.

• Smoking history in the last three months as per protocol.

• An unwillingness of male subjects to follow contraception methods as per protocol.

• History or presence of significant psychiatric, respiratory or gastrointestinal illnesses, hepatic or renal diseases or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.

• The subject is unable or unwilling to abstain from strenuous physical activity in the 48 hours before screening and in the 48 hours before and the 48 hours after the treatment period.

• Current or previous (within 6 months) participation in a clinical trial.