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NCT ID: NCT01928069 Completed - Healthy Clinical Trials

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed Conditions

Start date: n/a
Phase: Phase 1
Study type: Interventional

Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet. Dosing periods were separated by a washout period during fed study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

NCT ID: NCT01931501 Completed - Healthy Clinical Trials

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium Chewable Tablets 5mg Under Fasted Conditions

Start date: n/a
Phase: Phase 1
Study type: Interventional

Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium chewable 5 mg tablet and Innovator's(Merck)Singulair chewable 5 mg tablet. Dosing periods were separated by a washout period during fasted study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

NCT ID: NCT01931514 Completed - Healthy Clinical Trials

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium Chewable 5mg Tablet Under Fed Conditions

Start date: n/a
Phase: Phase 1
Study type: Interventional

Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium chewable 5mg tablet and Innovator's(Merck)Singulair chewable 5mg tablet. Dosing periods were separated by a washout period during fed study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

NCT ID: NCT01931813 Completed - Clinical trials for Infants Likely to Present Febrile Convulsions

METHORIVAC - Vaccinal Pharmacoepidemiologic

METHORIVAC
Start date: n/a
Phase: N/A
Study type: Observational

This project is the pilot step necessary to develop a system of vaccination pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for this challenge and case series analysis, with the use of linked medicoadministrative data for hospitalisations the reimbursement of healthcare costs. This linkage of medicoadministrative data is new in France. The example of the risk of hospitalisation for febrile convulsions in infants less than two years old following vaccination against diphtheria, tetanus and pertussis is given as the reference association. This choice is justified by the numerous publications over many years on the existence of this association (Miller et al BMJ 1981, Farrington et al Lancet 1995). In addition, as case series analyses have been carried out to assess this risk, the results can be compared directly (Lancet 1995). The study to determine whether the analysis tools are suitable for the data will be tackled at the following levels: - Validity of the selection of cases from administrative records alone using coding based on the international classification of diseases ICD10 - Validity of the risk assessment. This methodology feasibility project must make it possible to identify the different potential problems. This is a prerequisite necessary for the systematic implementation.

NCT ID: NCT01937663 Completed - Clinical trials for Chronic Constipation

A Single-blind, Dose-tapering Study of KWA-0711 in Patients With Chronic Constipation

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in chronic constipation patients.

NCT ID: NCT01938196 Completed - Clinical trials for Chronic Constipation

A Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in chronic constipation patients.

NCT ID: NCT01953211 Completed - Clinical trials for Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy

Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

Start date: n/a
Phase:
Study type: Observational

The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian axis during the hormone-free interval in combined oral contraceptive (COC) hormone users varies depending on the dose of ethinyl estradiol in the formulation. This variation in activation may be associated with different side effects during the hormone free interval. Progesterone (P) remained suppressed during all 6 COC regimens (<1.8 ng/mL), which indicates continuous contraceptive efficacy during the 7-day hormone free interval of all formulations studied.

NCT ID: NCT01958892 Completed - Clinical trials for Benign Prostatic Hyperplasia

To Compare Outcomes After Transurethral Enucleation of Prostate Versus Transurethral Resection of Prostate

Start date: n/a
Phase: N/A
Study type: Observational

The purpose of the study is to assess whether transurethral enucleation of prostate gives better or equivalent outcomes compared to the gold standard of transurethral resection of the prostate

NCT ID: NCT01969656 Completed - Clinical trials for Postmenopausal Osteoporosis, Multiple Sites

Safety Study of an Oral Vitamin D Analog in Postmenopausal Women

Start date: n/a
Phase: Phase 1
Study type: Interventional

Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.

NCT ID: NCT01970111 Completed - Clinical trials for Spinocerebellar Degeneration

An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Start date: n/a
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients.