Pharmacokinetics Study of XG005 Capsule

• Status: Completed
• Trial end date: 2018-03-19
• Target enrollment: 0
• Participant gender: All

Summary

This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending single-dose study assessing the PK, safety, and tolerability of single ascending doses of XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups each with 10 subjects.

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

Details

• Lead Sponsor: Xgene Pharmaceutical Pty Ltd
• Treatments: Naproxen; Pregabalin

Criteria

Inclusion Criteria:

• BMI range of 18-30 kg/m2

• Medically healthy subjects

• Creatinine clearance ≥ 80 mL/min

Exclusion Criteria:

• History or presence of significant diseases

• History or presence of alcoholism or drug abuse

• Consumption of alcohol 48 hours prior each dose

• Hypersensitivity or idiosyncratic reaction to the study drug

• Abnormal diet (for whatever reason) during the 30 days prior to the first dosing;

• Donation (standard donation amount or more) of blood or blood products

• Plasma donation within 7 days prior to the study;

• Participation in another clinical trial within 30 days prior to the first dose;

• Female subjects who are pregnant or lactating;

• Hemoglobin < 120 g/L