Phase 1 safety, tolerability, and pharmacokinetic study of single ascending doses of XM17 (recombinant human follicle-stimulating hormone) in downregulated healthy women

International Journal of Women's Health

Volumn 7, Issue , 2015, Pages 707-716

  Lammerich, Andreas ^a   Bias, Peter ^a   Gertz, Beate ^a  

^a TEVA PHARMACEUTICALS   (Israel)

Author keywords

Anovulation; Assisted reproductive technology; Biosimilar; Follitropin alfa

Indexed keywords

DRUG ANTIBODY; FOLLITROPIN; GONADORELIN AGONIST; GOSERELIN; ORAL CONTRACEPTIVE AGENT; RECOMBINANT FOLLITROPIN;

ACNE; ADULT; ANTIBODY DETECTION; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; DISEASE SEVERITY; DIZZINESS; DOWN REGULATION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE INCREASE; DRUG ELIMINATION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; EXPERIMENTAL STUDY; FEMALE; GASTROENTERITIS; HORDEOLUM; HOT FLUSH; HUMAN; HUMAN EXPERIMENT; INJECTION SITE PAIN; LIMB PAIN; LOW DRUG DOSE; LOWER ABDOMINAL PAIN; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; OTALGIA; PARALLEL DESIGN; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL; PILOT STUDY; PLASMA CONCENTRATION-TIME CURVE; PRURITUS; RHINOPHARYNGITIS; SINGLE DRUG DOSE; SKIN ALLERGY; TIME TO MAXIMUM PLASMA CONCENTRATION; URINARY TRACT INFECTION; VOLUME OF DISTRIBUTION; VOLUNTEER;

EID: 84938091621     PISSN: None     EISSN: 11791411     Source Type: Journal    
DOI: 10.2147/IJWH.S83418     Document Type: Article

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