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Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Vital Signs

- 18.09.19 - 1 Formulär, 10 Item-grupper, 37 Dataelement, 1 Språk
Item-grupper: Vital Signs, Dosage, Date in time, Time, Vital signs, Pre-dose, Vital signs, Post-dose, 1 Hour, Vital signs, 2 hours post-dose, Vital signs, 4 hours post-dose, Vital Signs, Post-dose, 6 Hours, Vital signs, Post-dose, 8 Hours, Vital signs, Post-dose, 10 Hours, Vital signs, Post-dose, 12 Hours, Vital signs, Post-dose, 24 Hours
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - PGx - Pharmacogenetic Research Consent

- 17.09.19 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Pharmacogenetic Test, Informed Consent
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - PGx - Pharmacogenetic Research Withdrawal of Consent

- 17.09.19 - 1 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: Pharmacogenetic Test, Informed Consent, Withdraw
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - PK Rpt

- 15.09.19 - 1 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk
Item-grupp: Pharmacokinetic aspects
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Electronically Transferred Lab Data

- 15.09.19 - 1 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: Laboratory Procedures
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Repeat Vital Signs

- 15.09.19 - 1 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: Vital signs
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - 12-Lead ECG Abnormalities

- 15.09.19 - 1 Formulär, 1 Item-grupp, 12 Dataelement, 1 Språk
Item-grupp: 12 lead ECG, Abnormality
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - 12-Lead ECG (ECG Rpt)

- 15.09.19 - 1 Formulär, 1 Item-grupp, 8 Dataelement, 1 Språk
Item-grupp: 12 lead ECG
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Concomitant Medication(s)

- 09.09.19 - 1 Formulär, 1 Item-grupp, 11 Dataelement, 1 Språk
Item-grupp: Concomitant Agent
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Adverse Events

- 09.09.19 - 1 Formulär, 1 Item-grupp, 16 Dataelement, 1 Språk
Item-grupp: Adverse Event
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Logs and Repeats

- 29.08.19 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Study Conclusion

- 29.08.19 - 1 Formulär, 1 Item-grupp, 7 Dataelement, 1 Språk
Item-grupp: Clinical Trials, Conclusion
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

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