CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS
CONTAINING 4 MG ACENOCUMAROL
GOALS AND OBJECTIVES
GENERAL: To determine the relative bioavailability of ACENOCUMAROL 4 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
24 volunteers screened and 20 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 400 MG ACYCLOVIR
GOALS AND OBJECTIVES
GENERAL: To determine the relative bioavailability of acyclovir 400 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
20 volunteers screened and 18 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 200 MG AMIODARONE HYDROCHLORIDE
GOALS AND OBJECTIVES
GENERAL: To determine the relative bioavailability of amiodarone hydrochloride 2 00 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
20 volunteers screened and 18 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 10 MG CETIRIZINE DIHYDROCHLORIDE
GOALS AND OBJECTIVES
GENERAL:
To determine the bioavailability of CETIRIZINE dihydrochloride 10 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period. Single doses of the test and reference forms are administered to healthy fasting volunteers.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
2 8 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 40 MG DROTAVERINE HYDROCHORIDE
GOALS AND OBJECTIVES
GENERAL:
To determine the bioavailability of DROTAVERINE hydrochoride 40 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period. Single doses of the test and reference forms are administered to healthy fasting volunteers.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
2 8 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 40 MG FAMOTIDINE
GOALS AND OBJECTIVES
GENERAL:
To determine the relative bioavailability of famotidine 40 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
24 volunteers screened and 20 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 10 MG LISINOPRIL
GOALS AND OBJECTIVES
GENERAL: To determine the relative bioavailability of LISINOPRIL 10 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL: To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
24 volunteers screened and 20 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 10 MG LORATADINE
GOALS AND OBJECTIVES
GENERAL: To determine the relative bioavailability of LORATADINE 10 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL: To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
24 volunteers screened and 20 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 25 MG MAPROTILINE HYDROCHLORIDE
GOALS AND OBJECTIVES
GENERAL: To determine the relative bioavailability of maprotiline hydrochloride 25 mg tablets in a test form and in a reference form in order to specify their bioequivalence.ivalence.
ADDITIONAL: To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
28 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 15 MG MELOXICAM
GOALS AND OBJECTIVES
GENERAL:
To determine the relative bioavailability of MELOXICAM 15 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL: To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
24 volunteers screened and 20 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 500 MG MESALAZINE
GOALS AND OBJECTIVES
GENERAL:
To determine the bioavailability of MESALAZINE 500 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period. Single doses of the test and reference forms are administered to healthy fasting volunteers.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-55.
NUMBER OF VOLUNTEERS
2 8 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 100 MG NIMESOLIDE
GOALS AND OBJECTIVES
GENERAL:
To determine the relative bioavailability of NIMESOLIDE 100 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
2 8 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
I/IV
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 20 MG PRAVASTATIN
GOALS AND OBJECTIVES
GENERAL: To determine the relative bioavailability of PRAVASTATIN 20 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL: To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
24 volunteers screened and 20 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 40 MG PROPRANOLOL HYDROCHLORIDE
GOALS AND OBJECTIVES
GENERAL:
To determine the relative bioavailability of PROPRANOLOL hydrochloride 40 mg film-coated tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL: To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
28 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 25 MG SIPROTELINE
GOALS AND OBJECTIVES
GENERAL:
To determine the relative bioavailability of SIPROTELINE 25 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-40.
NUMBER OF VOLUNTEERS
2 8 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 160 MG SOTALOL
GOALS AND OBJECTIVES
GENERAL:
To determine the relative bioavailability of SOTALOL 160 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
24 volunteers screened and 20 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 20 MG TAMOXIFEN CITRATE
GOALS AND OBJECTIVES
GENERAL: To determine the relative bioavailability of TAMOXIFEN CITRATE 20 mg tablets in a test form in a reference form in order to specify their bioequivalence.
ADDITIONAL: To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
44 volunteers screened and 40 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 250 MG TERBINAFINE HYDROCHLORIDE
GOALS AND OBJECTIVES
GENERAL: To determine the relative bioavailability of TERBINAFINE hydrochloride 250 mg tablets in a test form and in a referent form in order to specify their bioequivalence.
ADDITIONAL: To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
28 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 50 MG TRAMADOL HCL
GOALS AND OBJECTIVES
GENERAL:
To determine the relative bioavailability of TRAMADOL HCL 50 mg capsules in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
28 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
CLINICAL TRIAL FOR COMPARATIVE BIOAVAILABILITY OF TWO PRODUCTS CONTAINING 20 MG TRIMETAZIDINE DIHYDROCHLORIDE
GOALS AND OBJECTIVES
GENERAL:
To determine the relative bioavailability of SIPROTELINE dihydrochloride 20 mg tablets in a test form and in a reference form in order to specify their bioequivalence.
ADDITIONAL : To determine the efficacy and safety of these forms.
DESIGN OF THE CLINICAL TRIAL
Single center, open, randomized, cross-over with wash-out period. Single doses of the test and reference forms are administered to healthy fasting volunteers.
SELECTION OF VOLUNTEERS
Healthy men, volunteers, aged 18-45.
NUMBER OF VOLUNTEERS
2 8 volunteers screened and 24 of them included in the trial.
PHASE OF THE PROJECT
Bioavailability and bioequivalence
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