Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00871806
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 5

Study Details

Study Description

Brief Summary

The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Commercial tablet with water; Drug: ODT #1 without water; Drug: ODT #2 without water; Drug: ODT #1 with water; Drug: ODT #2 with water	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Phase 1, Open-Label, Randomized, Single-Dose, 5-Way Crossover Pilot Bioavailability Study Comparing Eletriptan Oral Disintegrating Tablet Formulations A And B Administered With Or Without Water To Relpax® Commercial Tablets Administered With Water
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Eletriptan commercial tablet with water Eletriptan commercial tablet given with water	Drug: Commercial tablet with water; 40 mg tablet, given once to each subject
Experimental: Eletriptan oral disintegrating tablet (ODT) #1 without water Oral disintegrating tablet formulation #1 without water	Drug: ODT #1 without water; 40 mg tablet given once to each subject
Experimental: Oral disintegrating tablet formulation (ODT) #2 without water Oral disintegrating tablet formulation #2 without water	Drug: ODT #2 without water; 40 mg tablet given once to each subject
Experimental: Oral disintegrating tablet formulation (ODT) #1 with water Oral disintegrating tablet formulation (ODT) #1 with water	Drug: ODT #1 with water; 40 mg tablet given once to each subject
Experimental: Oral disintegrating tablet formulation (ODT) #2 with water Oral disintegrating tablet formulation (ODT) #2 with water	Drug: ODT #2 with water; 40 mg tablet given once to each subject

Outcome Measures

Primary Outcome Measures

1. Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax) [24 hr]

Secondary Outcome Measures

1. Time of peak eletriptan concentrations (Tmax), half life [24 hr]

2. Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy subjects

• No CYP3A4 inhibitors

Exclusion Criteria:

• Clinically significant disease in any organ system

• Positive urine drug screen

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Singapore		Singapore	188770

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00871806
• Other Study ID Numbers: A1601122
• First Posted: Mar 30, 2009
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by , ,: Pharmacokinetics; eletriptan; bioavailability; oral disintegrating tablet

Study Results

No Results Posted as of Jan 27, 2021