NCT01133444

Brief Summary

The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck \& Co. (Propecia®) 1 mg finasteride tablets under fasting conditions following administration of a 3 mg dose.

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 Apr 2002

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

April 1, 2002

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
Last Updated

July 12, 2010

Status Verified

May 1, 2010

Enrollment Period

Same day

First QC Date

May 27, 2010

Last Update Submit

July 9, 2010

Conditions

Healthy

Keywords

Bioequivalence,Finasteride,Crossover

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on Cmax and AUC parameters

    3 months

Study Arms (2)

Finasteride

EXPERIMENTAL

Finasteride tablets 1 mg of Dr. Reddy's

Drug: Finasteride

Propecia

ACTIVE COMPARATOR

Propecia 1 mgTablets of Merck \& Co.,

Drug: Finasteride

Interventions

FinasterideDRUG

Finasteride tablets 1 mg

Also known as: Propecia
FinasteridePropecia

Eligibility Criteria

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

You may not qualify if:

  • History or presence of significant:
  • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
  • In addition, history or presence of:
  • alcoholism or drug abuse within the past year;
  • hypersensitivity or idiosyncratic reaction to finasteride or any other 5-a reductase inhibitor.
  • Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
  • Subjects who, through completion of the study, would have donated in excess of:
  • mL of blood in 14 days, or
  • mL of blood in 14 days (unless approved by the Principal Investigator),
  • mL of blood in 90 days,
  • mL of blood in 120 days,
  • mL of blood in 180 days,
  • mL of blood in 270 days,
  • mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Cohen Street, Saint-laurent, Montreal (quebec), H4R 2N6, Canada

Location

MeSH Terms

Interventions

Finasteride

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAzasteroidsSteroids, Heterocyclic

Study Officials

  • Gaetano Morelli, MD

    MDS Pharma Services

    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 27, 2010

First Posted

May 28, 2010

Study Start

April 1, 2002

Primary Completion

April 1, 2002

Study Completion

May 1, 2002

Last Updated

July 12, 2010

Record last verified: 2010-05

Locations

CA(1)