Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers

Summary

Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.

Timeline

Start

2013-07-15

Primary completion

2013-08-22

Completion

2013-08-22

Outcome

Mixed primary results

paper Geometric least squares mean ratios (90% confidence intervals [CIs]) for D-amphetamine (active moiety) were within the prespecified bioequivalence range (0.80-1.25) PMID 27661399 ↗

paper ratios (90% CIs) for LDX (inactive prodrug) were below the accepted range when the contents of a 70-mg LDX capsule were mixed with orange juice PMID 27661399 ↗

paper lower 90% CI for Cmax [0.828 (0.752, 0.912)] was below the accepted range when the contents of a 70-mg LDX capsule were mixed with yogurt. PMID 27661399 ↗

Publications

• Results Ermer J, Corcoran M, Lasseter K, Martin PT. Relative Bioavailabilities of Lisdexamfetamine Dimesylate and D-Amphetamine in Healthy Adults in an Open-Label, Randomized, Crossover Study After Mixing Lisdexamfetamine Dimesylate With Food or Drink. Ther Drug Monit. 2016 Dec;38(6):769-776. doi: 10.1097/FTD.0000000000000343.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lisdexamfetamine Dimesylate	Small molecule	70 mg	Oral

Indications

No indication recorded.