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Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01122953
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
2
Duration (Months)
17
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Bioequivalence study in healthy volunteers

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Bioequivalence Study Of 5ml Dose Of PHENYTOIN 125mg/ 5ml Suspension Made By Laboratorios Pfizer, S.A. De C.V. Versus EPAMIN® 125 mg/5ml Made By McNeil LA LLC, Study In Healthy Volunteers Under Fasting Conditions
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phenytoin

Drug: Phenytoin
Single dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.
Active Comparator: Epamin

Drug: Epamin
Single dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC

Outcome Measures

Primary Outcome Measures

  1. Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method. [0-168 h]

  2. Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval. [0-168 h]

  3. Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed. [0-168 h]

Secondary Outcome Measures

  1. Constant of elimination (ke): Will be determined as the slope from the linear logarithmic regression of the terminal phase of the logarithmic graph of concentration over time. [0-168 h]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years

  • Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight >50 kg (110 lbs).

  • An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

  • Any condition possibly affecting drug absorption (eg, gastrectomy).

  • A positive urine drug screen.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Mexico Distrito Federal Mexico 14050

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:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT01122953
Other Study ID Numbers:
  • A4121009
First Posted:
May 13, 2010
Last Update Posted:
Jan 27, 2021
Last Verified:
Jul 1, 2010
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bioequivalence
EPAMIN
PHENYTOIN
Additional relevant MeSH terms:
Phenytoin

Study Results

No Results Posted as of Jan 27, 2021