NCT01132040

Brief Summary

The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of Dr.Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, in healthy, adult, human subjects under fasting conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

1 month

First QC Date

May 26, 2010

Last Update Submit

May 26, 2010

Conditions

Healthy

Keywords

BioequivalenceCrossoverPrimidone

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on Cmax and AUC parameters

    2 months

Study Arms (2)

Primidone

EXPERIMENTAL

Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories

Drug: Primidone

Mysoline

ACTIVE COMPARATOR

Mysoline Tablets of Yamanouchi Pharma Technologies Inc,

Drug: Primidone

Interventions

PrimidoneDRUG

Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories Limited

Also known as: Mysoline
MysolinePrimidone

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who will provide written informed consent.
  • Subjects must be healthy, adult, human beings within 18-45 years of age (both inclusive)weighing at least 50 kg.
  • Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
  • Subjects must be of normal health as determined by medical history and physical examination performed within 21 days prior to the commencement of the study.
  • Subjects whose screening laboratory values are within normal limits or considered by the physician/investigator to be of no clinical significance.
  • Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent.

You may not qualify if:

  • The subjects will be excluded based on the following criteria during screening and during the study
  • Subjects incapable of understanding the informed consent.
  • Subjects who have:
  • Systolic blood pressure less than 90 mm ofHg or more than 140 mm of Hg
  • Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician/investigator.
  • Pulse rate below 50/min or above 100/min.
  • History of hypersensitivity or idiosyncratic reaction to study drug or any other related drugs.
  • Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
  • Consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study.
  • Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and during sampling period.
  • Subjects who have taken over the counter or prescribed medications and enzyme modifying or any systemic medication for during the last 7 and 30 days respectively before dosing.
  • Subjects who have participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
  • Subjects with clinically significant abnormalities (such as Laboratory Findings, ECG, X-Ray,Drugs of abuse, Alcohol etc.,) and/or with significant diseases (such as HIV, Hey, Syphilis,Hepatitis B etc.,).
  • Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bioserve Clinical Research Pvt. Ltd,

HYD, Andhra Pradesh, 500 037, India

Location

MeSH Terms

Interventions

Primidone

Intervention Hierarchy (Ancestors)

PhenobarbitalBarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mohanlal shiva prasad sayana

    Bioserve Clinical Research Pvt. Ltd., Hyderabad, A.P.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 27, 2010

Study Start

August 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

IN(1)