NCT00648466

CompletedPhase 1

Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imi...

Mylan Pharmaceuticals Inc Source

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Other study identifiers

Sponsor study identifier

SUMA-0358

Study Type

interventional

Actual enrollment (reported)

55

Locations

1 country

Sites

1

Timeline

Study Start

November 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2004

Actual (reported)

Study Completion

December 2004

Actual (reported)

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fasting conditions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 55 participants
Study completion date: December 2004
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2004
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2004
Actual (reported)
Study Completion
December 2004
Actual (reported)
First Submitted
March 30, 2008
Actual (reported)
First Posted
April 1, 2008
Actual (reported)

Last Updated: December 1, 2009
Status Verified: November 2009
Last Update Submitted: November 30, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
Blood collections through 16 hours

Study Arms (2)

1

EXPERIMENTAL

Sumatriptan Succinate Tablets 100 mg

Drug: Sumatriptan Succinate Tablets 100 mg

2

ACTIVE COMPARATOR

Imitrex® Tablets 100 mg

Drug: Imitrex® Tablets 100 mg

Interventions

Sumatriptan Succinate Tablets 100 mgDrug

100mg, single dose fasting

1

Imitrex® Tablets 100 mgDrug

100mg, single dose fasting

2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age: 18 years and older.
Sex: Male and/or non-pregnant, non-lactating female.

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

MeSH Terms

Interventions

Sumatriptan

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Dorian Williams, M.D.
Kendle International Inc.
PRINCIPAL INVESTIGATOR

Enrollment

55 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 1, 2008

Study Start

November 2004

Date type not reported

This date has not been verified as actual or estimated.

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Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on weekends, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.

Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:

intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or

barrier methods containing or used in conjunction with a spermicidal agent, or

surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.

During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.

Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).

All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

You may not qualify if:

Institutionalized subjects will not be used.
Social Habits:
Use of any tobacco products within 1 year of the start of the study.
Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
Ingestion of any vitamins or herbal products within the 7 days prior to the initial dose of the study medication.
Any recent, significant change in dietary or exercise habits.
A positive test for any drug included in the urine drug screen.
History of drug and/or alcohol abuse.
Medications:
Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
Use of any hormonal contraceptives and hormone replacement therapy within 3 months prior to study medication dosing.
Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
Diseases:
History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
Acute illness at the time of either the pre-study medical evaluation or dosing.
+8 more criteria

Contact the study team to confirm eligibility.

Primary Completion

December 2004

Actual (reported)

Study Completion

December 2004

Actual (reported)

Last Updated

December 1, 2009

Record last verified: 2009-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00648466
Data provider: ClinicalTrials.gov
Source updated: 2009-12-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:02 UTC

Locations

US(1)

Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations